ByHeart Formula Botulism Outbreak Ends After Dozens of Babies Sickened
Nationwide, Washington
Published · Updated
Summary
- The CDC has declared the ByHeart infant botulism outbreak over, with 48 infants hospitalized across 19 states and no deaths reported.
- The outbreak, linked to contaminated ByHeart formula, prompted a nationwide recall and FDA warnings to major retailers for continued sales post-recall. Despite extensive investigation, the definitive source of contamination remains unidentified, though powdered whole milk was suspected.
Timeline
The FDA identified 17 strains of the bacteria across patient samples, formula cans, and ingredients, but the root cause remains unknown. Officials previously said contamination may have involved powdered whole milk.
Health officials revised the final case count to 48 infants after previously reported cases were determined not to be botulism-related. Investigators have not identified a definitive source of contamination.
The CDC has declared the ByHeart infant botulism outbreak over, with no new cases reported since mid-December. A total of 48 babies were sickened, all hospitalized, and no deaths were reported.
Walmart officials claimed that no ByHeart formula was sold after cash registers were blocked from selling the formula following the recall. Albertsons officials said the company worked closely with suppliers and regulators to identify and remove the products and communicate to customers.
The companies reportedly failed to provide the FDA with evidence that corrective actions had been implemented, despite multiple requests, the agency said.
ByHeart formula was found at Walmart stores in 21 states from Nov. 12 to Nov. 26, Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19, officials said.
The formula was reportedly found at Target stores in 20 states “well after the recall was initiated,” one letter said. It also noted that a Target store in Arkansas promoted single-serve packs of ByHeart formula with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” FDA officials said in warning letters sent to the companies on Dec. 12.
The FDA sent warning letters to Walmart, Target, Kroger, and Albertsons after finding they continued selling recalled ByHeart infant formula tied to a nationwide botulism outbreak. The agency gave retailers 15 working days to explain corrective steps, warning unresolved violations could lead to legal action.
Fifty-one babies in 19 states have now been sickened with infant botulism tied to contaminated ByHeart formula, health officials said this week. Ohio is the latest state to be added to the outbreak list. No deaths have yet been reported.
States with Cases as of Dec. 3: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, VA, WA, WI.
As of Dec. 3, 39 cases of confirmed or suspected illness in 18 states have been reported among babies who consumed ByHeart formula since August, according to the FDA.
Officials are coordinating with state health authorities to verify these reports.
Reports have been submitted to the FDA of formula remaining for purchase after the initial recall in multiple states.
Officials have reported that 37 infants have been hospitalized in relation to the infant botulism outbreak.
The FDA and CDC provided an update on the ongoing investigation.
The American Academy of Pediatrics reports that symptoms typically appear between 3 and 30 days after exposure and may include: - Constipation - Poor feeding or difficulty sucking/swallowing - Weak or altered cry - Reduced facial expression - Drooping eyelids - Loss of head control - Lethargy or decreased movement.
ByHeart again urges families to stop using all ByHeart formula immediately.
ByHeart has introduced a revised refund policy effective Nov. 24. Families who purchased products on ByHeart.com on or after Aug. 1 are now eligible for full refunds.
ByHeart says it is continuing a review of its entire supply chain, including raw materials, production processes, packaging, and transport, and is testing additional samples as part of the investigation.
"Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," ByHeart posted on its website.
ByHeart said in a post on Nov. 24 that five of 36 samples tested positive for Clostridium botulinum Type A.
As of Nov. 19, the CDC said the outbreak has increased to 31 infants with suspected or confirmed infant botulism from 15 states. No deaths have been reported.
The number of baby botulism cases linked to recalled ByHeart formula has reached 23 as of Friday, health officials say. The outbreak stretches across 13 states, with the most recent case reported on November 11. No deaths have been reported. Parents are urged to immediately stop using ByHeart infant formula.
Parents and caregivers should immediately stop using any ByHeart formula, record the lot number, seal and label leftovers “DO NOT USE,” and watch for botulism symptoms including constipation, weak crying, drooping eyelids, poor feeding, or trouble breathing.
The voluntary recall now covers all batches of ByHeart Whole Nutrition Infant Formula — including every lot number, in all cans and each Anywhere Pack™ single-serve packet.
A suspected case in Nassau County, New York, is under review, while North Carolina officials are investigating a possible new case connected to the recalled baby formula.
Health officials have confirmed 15 infant botulism cases across 12 states. The number increased from 13 cases previously reported in 10 states as more health departments confirmed infections.
Per KHOU, health officials are warning parents not to feed certain lots of ByHeart baby formula to infants amid a multistate botulism investigation. According to the U.S. Food and Drug Administration, at least 13 infants have been hospitalized across 10 states — Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington — after consuming the formula between August and November. The most recent illness occurred in November. All hospitalized infants reportedly consumed ByHeart powdered formula, according to the FDA. Botulism is a serious illness caused by a toxin that attacks the nerves, potentially leading to difficulty breathing, paralysis, or death. In infants, symptoms may include constipation, poor feeding, trouble swallowing, weakness, and loss of head control. These signs can take weeks to appear. ByHeart stated it was notified Friday of 83 cases of infant botulism reported nationwide since August. The company has voluntarily recalled its Whole Nutrition Infant Formula, lot numbers 206VABP/251131P2 and 206VABP/251261P2, both with a use-by date of Dec. 1, 2026. The lot numbers are printed on the bottom of each can. The affected formula was sold both online and in major retail stores nationwide. Consumers are urged to check their cans, note the affected lot numbers, and discard the product immediately. Health officials advise anyone who suspects exposure or observes these symptoms in an infant to seek medical care immediately.
Incident reported at 395 E St SW.
The FDA identified 17 strains of the bacteria across patient samples, formula cans, and ingredients, but the root cause remains unknown. Officials previously said contamination may have involved powdered whole milk.
Health officials revised the final case count to 48 infants after previously reported cases were determined not to be botulism-related. Investigators have not identified a definitive source of contamination.
The CDC has declared the ByHeart infant botulism outbreak over, with no new cases reported since mid-December. A total of 48 babies were sickened, all hospitalized, and no deaths were reported.
Walmart officials claimed that no ByHeart formula was sold after cash registers were blocked from selling the formula following the recall. Albertsons officials said the company worked closely with suppliers and regulators to identify and remove the products and communicate to customers.
The companies reportedly failed to provide the FDA with evidence that corrective actions had been implemented, despite multiple requests, the agency said.
ByHeart formula was found at Walmart stores in 21 states from Nov. 12 to Nov. 26, Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19, officials said.
The formula was reportedly found at Target stores in 20 states “well after the recall was initiated,” one letter said. It also noted that a Target store in Arkansas promoted single-serve packs of ByHeart formula with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” FDA officials said in warning letters sent to the companies on Dec. 12.
The FDA sent warning letters to Walmart, Target, Kroger, and Albertsons after finding they continued selling recalled ByHeart infant formula tied to a nationwide botulism outbreak. The agency gave retailers 15 working days to explain corrective steps, warning unresolved violations could lead to legal action.
Fifty-one babies in 19 states have now been sickened with infant botulism tied to contaminated ByHeart formula, health officials said this week. Ohio is the latest state to be added to the outbreak list. No deaths have yet been reported.
States with Cases as of Dec. 3: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, VA, WA, WI.
As of Dec. 3, 39 cases of confirmed or suspected illness in 18 states have been reported among babies who consumed ByHeart formula since August, according to the FDA.
Officials are coordinating with state health authorities to verify these reports.
Reports have been submitted to the FDA of formula remaining for purchase after the initial recall in multiple states.
Officials have reported that 37 infants have been hospitalized in relation to the infant botulism outbreak.
The FDA and CDC provided an update on the ongoing investigation.
The American Academy of Pediatrics reports that symptoms typically appear between 3 and 30 days after exposure and may include: - Constipation - Poor feeding or difficulty sucking/swallowing - Weak or altered cry - Reduced facial expression - Drooping eyelids - Loss of head control - Lethargy or decreased movement.
ByHeart again urges families to stop using all ByHeart formula immediately.
ByHeart has introduced a revised refund policy effective Nov. 24. Families who purchased products on ByHeart.com on or after Aug. 1 are now eligible for full refunds.
ByHeart says it is continuing a review of its entire supply chain, including raw materials, production processes, packaging, and transport, and is testing additional samples as part of the investigation.
"Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," ByHeart posted on its website.
ByHeart said in a post on Nov. 24 that five of 36 samples tested positive for Clostridium botulinum Type A.
As of Nov. 19, the CDC said the outbreak has increased to 31 infants with suspected or confirmed infant botulism from 15 states. No deaths have been reported.
The number of baby botulism cases linked to recalled ByHeart formula has reached 23 as of Friday, health officials say. The outbreak stretches across 13 states, with the most recent case reported on November 11. No deaths have been reported. Parents are urged to immediately stop using ByHeart infant formula.
Parents and caregivers should immediately stop using any ByHeart formula, record the lot number, seal and label leftovers “DO NOT USE,” and watch for botulism symptoms including constipation, weak crying, drooping eyelids, poor feeding, or trouble breathing.
The voluntary recall now covers all batches of ByHeart Whole Nutrition Infant Formula — including every lot number, in all cans and each Anywhere Pack™ single-serve packet.
A suspected case in Nassau County, New York, is under review, while North Carolina officials are investigating a possible new case connected to the recalled baby formula.
Health officials have confirmed 15 infant botulism cases across 12 states. The number increased from 13 cases previously reported in 10 states as more health departments confirmed infections.
Per KHOU, health officials are warning parents not to feed certain lots of ByHeart baby formula to infants amid a multistate botulism investigation. According to the U.S. Food and Drug Administration, at least 13 infants have been hospitalized across 10 states — Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington — after consuming the formula between August and November. The most recent illness occurred in November. All hospitalized infants reportedly consumed ByHeart powdered formula, according to the FDA. Botulism is a serious illness caused by a toxin that attacks the nerves, potentially leading to difficulty breathing, paralysis, or death. In infants, symptoms may include constipation, poor feeding, trouble swallowing, weakness, and loss of head control. These signs can take weeks to appear. ByHeart stated it was notified Friday of 83 cases of infant botulism reported nationwide since August. The company has voluntarily recalled its Whole Nutrition Infant Formula, lot numbers 206VABP/251131P2 and 206VABP/251261P2, both with a use-by date of Dec. 1, 2026. The lot numbers are printed on the bottom of each can. The affected formula was sold both online and in major retail stores nationwide. Consumers are urged to check their cans, note the affected lot numbers, and discard the product immediately. Health officials advise anyone who suspects exposure or observes these symptoms in an infant to seek medical care immediately.
Incident reported at 395 E St SW.
The FDA identified 17 strains of the bacteria across patient samples, formula cans, and ingredients, but the root cause remains unknown. Officials previously said contamination may have involved powdered whole milk.
Health officials revised the final case count to 48 infants after previously reported cases were determined not to be botulism-related. Investigators have not identified a definitive source of contamination.
The CDC has declared the ByHeart infant botulism outbreak over, with no new cases reported since mid-December. A total of 48 babies were sickened, all hospitalized, and no deaths were reported.
Walmart officials claimed that no ByHeart formula was sold after cash registers were blocked from selling the formula following the recall. Albertsons officials said the company worked closely with suppliers and regulators to identify and remove the products and communicate to customers.
The companies reportedly failed to provide the FDA with evidence that corrective actions had been implemented, despite multiple requests, the agency said.
ByHeart formula was found at Walmart stores in 21 states from Nov. 12 to Nov. 26, Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19, officials said.
The formula was reportedly found at Target stores in 20 states “well after the recall was initiated,” one letter said. It also noted that a Target store in Arkansas promoted single-serve packs of ByHeart formula with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” FDA officials said in warning letters sent to the companies on Dec. 12.
The FDA sent warning letters to Walmart, Target, Kroger, and Albertsons after finding they continued selling recalled ByHeart infant formula tied to a nationwide botulism outbreak. The agency gave retailers 15 working days to explain corrective steps, warning unresolved violations could lead to legal action.
Fifty-one babies in 19 states have now been sickened with infant botulism tied to contaminated ByHeart formula, health officials said this week. Ohio is the latest state to be added to the outbreak list. No deaths have yet been reported.
States with Cases as of Dec. 3: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, VA, WA, WI.
As of Dec. 3, 39 cases of confirmed or suspected illness in 18 states have been reported among babies who consumed ByHeart formula since August, according to the FDA.
Officials are coordinating with state health authorities to verify these reports.
Reports have been submitted to the FDA of formula remaining for purchase after the initial recall in multiple states.
Officials have reported that 37 infants have been hospitalized in relation to the infant botulism outbreak.
The FDA and CDC provided an update on the ongoing investigation.
The American Academy of Pediatrics reports that symptoms typically appear between 3 and 30 days after exposure and may include: - Constipation - Poor feeding or difficulty sucking/swallowing - Weak or altered cry - Reduced facial expression - Drooping eyelids - Loss of head control - Lethargy or decreased movement.
ByHeart again urges families to stop using all ByHeart formula immediately.
ByHeart has introduced a revised refund policy effective Nov. 24. Families who purchased products on ByHeart.com on or after Aug. 1 are now eligible for full refunds.
ByHeart says it is continuing a review of its entire supply chain, including raw materials, production processes, packaging, and transport, and is testing additional samples as part of the investigation.
"Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," ByHeart posted on its website.
ByHeart said in a post on Nov. 24 that five of 36 samples tested positive for Clostridium botulinum Type A.
As of Nov. 19, the CDC said the outbreak has increased to 31 infants with suspected or confirmed infant botulism from 15 states. No deaths have been reported.
The number of baby botulism cases linked to recalled ByHeart formula has reached 23 as of Friday, health officials say. The outbreak stretches across 13 states, with the most recent case reported on November 11. No deaths have been reported. Parents are urged to immediately stop using ByHeart infant formula.
Parents and caregivers should immediately stop using any ByHeart formula, record the lot number, seal and label leftovers “DO NOT USE,” and watch for botulism symptoms including constipation, weak crying, drooping eyelids, poor feeding, or trouble breathing.
The voluntary recall now covers all batches of ByHeart Whole Nutrition Infant Formula — including every lot number, in all cans and each Anywhere Pack™ single-serve packet.
A suspected case in Nassau County, New York, is under review, while North Carolina officials are investigating a possible new case connected to the recalled baby formula.
Health officials have confirmed 15 infant botulism cases across 12 states. The number increased from 13 cases previously reported in 10 states as more health departments confirmed infections.
Per KHOU, health officials are warning parents not to feed certain lots of ByHeart baby formula to infants amid a multistate botulism investigation. According to the U.S. Food and Drug Administration, at least 13 infants have been hospitalized across 10 states — Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington — after consuming the formula between August and November. The most recent illness occurred in November. All hospitalized infants reportedly consumed ByHeart powdered formula, according to the FDA. Botulism is a serious illness caused by a toxin that attacks the nerves, potentially leading to difficulty breathing, paralysis, or death. In infants, symptoms may include constipation, poor feeding, trouble swallowing, weakness, and loss of head control. These signs can take weeks to appear. ByHeart stated it was notified Friday of 83 cases of infant botulism reported nationwide since August. The company has voluntarily recalled its Whole Nutrition Infant Formula, lot numbers 206VABP/251131P2 and 206VABP/251261P2, both with a use-by date of Dec. 1, 2026. The lot numbers are printed on the bottom of each can. The affected formula was sold both online and in major retail stores nationwide. Consumers are urged to check their cans, note the affected lot numbers, and discard the product immediately. Health officials advise anyone who suspects exposure or observes these symptoms in an infant to seek medical care immediately.
Incident reported at 395 E St SW.
The FDA identified 17 strains of the bacteria across patient samples, formula cans, and ingredients, but the root cause remains unknown. Officials previously said contamination may have involved powdered whole milk.
Health officials revised the final case count to 48 infants after previously reported cases were determined not to be botulism-related. Investigators have not identified a definitive source of contamination.
The CDC has declared the ByHeart infant botulism outbreak over, with no new cases reported since mid-December. A total of 48 babies were sickened, all hospitalized, and no deaths were reported.
Walmart officials claimed that no ByHeart formula was sold after cash registers were blocked from selling the formula following the recall. Albertsons officials said the company worked closely with suppliers and regulators to identify and remove the products and communicate to customers.
The companies reportedly failed to provide the FDA with evidence that corrective actions had been implemented, despite multiple requests, the agency said.
ByHeart formula was found at Walmart stores in 21 states from Nov. 12 to Nov. 26, Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19, officials said.
The formula was reportedly found at Target stores in 20 states “well after the recall was initiated,” one letter said. It also noted that a Target store in Arkansas promoted single-serve packs of ByHeart formula with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” FDA officials said in warning letters sent to the companies on Dec. 12.
The FDA sent warning letters to Walmart, Target, Kroger, and Albertsons after finding they continued selling recalled ByHeart infant formula tied to a nationwide botulism outbreak. The agency gave retailers 15 working days to explain corrective steps, warning unresolved violations could lead to legal action.
Fifty-one babies in 19 states have now been sickened with infant botulism tied to contaminated ByHeart formula, health officials said this week. Ohio is the latest state to be added to the outbreak list. No deaths have yet been reported.
States with Cases as of Dec. 3: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, VA, WA, WI.
As of Dec. 3, 39 cases of confirmed or suspected illness in 18 states have been reported among babies who consumed ByHeart formula since August, according to the FDA.
Officials are coordinating with state health authorities to verify these reports.
Reports have been submitted to the FDA of formula remaining for purchase after the initial recall in multiple states.
Officials have reported that 37 infants have been hospitalized in relation to the infant botulism outbreak.
The FDA and CDC provided an update on the ongoing investigation.
The American Academy of Pediatrics reports that symptoms typically appear between 3 and 30 days after exposure and may include: - Constipation - Poor feeding or difficulty sucking/swallowing - Weak or altered cry - Reduced facial expression - Drooping eyelids - Loss of head control - Lethargy or decreased movement.
ByHeart again urges families to stop using all ByHeart formula immediately.
ByHeart has introduced a revised refund policy effective Nov. 24. Families who purchased products on ByHeart.com on or after Aug. 1 are now eligible for full refunds.
ByHeart says it is continuing a review of its entire supply chain, including raw materials, production processes, packaging, and transport, and is testing additional samples as part of the investigation.
"Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," ByHeart posted on its website.
ByHeart said in a post on Nov. 24 that five of 36 samples tested positive for Clostridium botulinum Type A.
As of Nov. 19, the CDC said the outbreak has increased to 31 infants with suspected or confirmed infant botulism from 15 states. No deaths have been reported.
The number of baby botulism cases linked to recalled ByHeart formula has reached 23 as of Friday, health officials say. The outbreak stretches across 13 states, with the most recent case reported on November 11. No deaths have been reported. Parents are urged to immediately stop using ByHeart infant formula.
Parents and caregivers should immediately stop using any ByHeart formula, record the lot number, seal and label leftovers “DO NOT USE,” and watch for botulism symptoms including constipation, weak crying, drooping eyelids, poor feeding, or trouble breathing.
The voluntary recall now covers all batches of ByHeart Whole Nutrition Infant Formula — including every lot number, in all cans and each Anywhere Pack™ single-serve packet.
A suspected case in Nassau County, New York, is under review, while North Carolina officials are investigating a possible new case connected to the recalled baby formula.
Health officials have confirmed 15 infant botulism cases across 12 states. The number increased from 13 cases previously reported in 10 states as more health departments confirmed infections.
Per KHOU, health officials are warning parents not to feed certain lots of ByHeart baby formula to infants amid a multistate botulism investigation. According to the U.S. Food and Drug Administration, at least 13 infants have been hospitalized across 10 states — Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington — after consuming the formula between August and November. The most recent illness occurred in November. All hospitalized infants reportedly consumed ByHeart powdered formula, according to the FDA. Botulism is a serious illness caused by a toxin that attacks the nerves, potentially leading to difficulty breathing, paralysis, or death. In infants, symptoms may include constipation, poor feeding, trouble swallowing, weakness, and loss of head control. These signs can take weeks to appear. ByHeart stated it was notified Friday of 83 cases of infant botulism reported nationwide since August. The company has voluntarily recalled its Whole Nutrition Infant Formula, lot numbers 206VABP/251131P2 and 206VABP/251261P2, both with a use-by date of Dec. 1, 2026. The lot numbers are printed on the bottom of each can. The affected formula was sold both online and in major retail stores nationwide. Consumers are urged to check their cans, note the affected lot numbers, and discard the product immediately. Health officials advise anyone who suspects exposure or observes these symptoms in an infant to seek medical care immediately.
Incident reported at 395 E St SW.
The FDA identified 17 strains of the bacteria across patient samples, formula cans, and ingredients, but the root cause remains unknown. Officials previously said contamination may have involved powdered whole milk.
Health officials revised the final case count to 48 infants after previously reported cases were determined not to be botulism-related. Investigators have not identified a definitive source of contamination.
The CDC has declared the ByHeart infant botulism outbreak over, with no new cases reported since mid-December. A total of 48 babies were sickened, all hospitalized, and no deaths were reported.
Walmart officials claimed that no ByHeart formula was sold after cash registers were blocked from selling the formula following the recall. Albertsons officials said the company worked closely with suppliers and regulators to identify and remove the products and communicate to customers.
The companies reportedly failed to provide the FDA with evidence that corrective actions had been implemented, despite multiple requests, the agency said.
ByHeart formula was found at Walmart stores in 21 states from Nov. 12 to Nov. 26, Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19, officials said.
The formula was reportedly found at Target stores in 20 states “well after the recall was initiated,” one letter said. It also noted that a Target store in Arkansas promoted single-serve packs of ByHeart formula with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” FDA officials said in warning letters sent to the companies on Dec. 12.
The FDA sent warning letters to Walmart, Target, Kroger, and Albertsons after finding they continued selling recalled ByHeart infant formula tied to a nationwide botulism outbreak. The agency gave retailers 15 working days to explain corrective steps, warning unresolved violations could lead to legal action.
Fifty-one babies in 19 states have now been sickened with infant botulism tied to contaminated ByHeart formula, health officials said this week. Ohio is the latest state to be added to the outbreak list. No deaths have yet been reported.
States with Cases as of Dec. 3: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, VA, WA, WI.
As of Dec. 3, 39 cases of confirmed or suspected illness in 18 states have been reported among babies who consumed ByHeart formula since August, according to the FDA.
Officials are coordinating with state health authorities to verify these reports.
Reports have been submitted to the FDA of formula remaining for purchase after the initial recall in multiple states.
Officials have reported that 37 infants have been hospitalized in relation to the infant botulism outbreak.
The FDA and CDC provided an update on the ongoing investigation.
The American Academy of Pediatrics reports that symptoms typically appear between 3 and 30 days after exposure and may include: - Constipation - Poor feeding or difficulty sucking/swallowing - Weak or altered cry - Reduced facial expression - Drooping eyelids - Loss of head control - Lethargy or decreased movement.
ByHeart again urges families to stop using all ByHeart formula immediately.
ByHeart has introduced a revised refund policy effective Nov. 24. Families who purchased products on ByHeart.com on or after Aug. 1 are now eligible for full refunds.
ByHeart says it is continuing a review of its entire supply chain, including raw materials, production processes, packaging, and transport, and is testing additional samples as part of the investigation.
"Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," ByHeart posted on its website.
ByHeart said in a post on Nov. 24 that five of 36 samples tested positive for Clostridium botulinum Type A.
As of Nov. 19, the CDC said the outbreak has increased to 31 infants with suspected or confirmed infant botulism from 15 states. No deaths have been reported.
The number of baby botulism cases linked to recalled ByHeart formula has reached 23 as of Friday, health officials say. The outbreak stretches across 13 states, with the most recent case reported on November 11. No deaths have been reported. Parents are urged to immediately stop using ByHeart infant formula.
Parents and caregivers should immediately stop using any ByHeart formula, record the lot number, seal and label leftovers “DO NOT USE,” and watch for botulism symptoms including constipation, weak crying, drooping eyelids, poor feeding, or trouble breathing.
The voluntary recall now covers all batches of ByHeart Whole Nutrition Infant Formula — including every lot number, in all cans and each Anywhere Pack™ single-serve packet.
A suspected case in Nassau County, New York, is under review, while North Carolina officials are investigating a possible new case connected to the recalled baby formula.
Health officials have confirmed 15 infant botulism cases across 12 states. The number increased from 13 cases previously reported in 10 states as more health departments confirmed infections.
Per KHOU, health officials are warning parents not to feed certain lots of ByHeart baby formula to infants amid a multistate botulism investigation. According to the U.S. Food and Drug Administration, at least 13 infants have been hospitalized across 10 states — Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington — after consuming the formula between August and November. The most recent illness occurred in November. All hospitalized infants reportedly consumed ByHeart powdered formula, according to the FDA. Botulism is a serious illness caused by a toxin that attacks the nerves, potentially leading to difficulty breathing, paralysis, or death. In infants, symptoms may include constipation, poor feeding, trouble swallowing, weakness, and loss of head control. These signs can take weeks to appear. ByHeart stated it was notified Friday of 83 cases of infant botulism reported nationwide since August. The company has voluntarily recalled its Whole Nutrition Infant Formula, lot numbers 206VABP/251131P2 and 206VABP/251261P2, both with a use-by date of Dec. 1, 2026. The lot numbers are printed on the bottom of each can. The affected formula was sold both online and in major retail stores nationwide. Consumers are urged to check their cans, note the affected lot numbers, and discard the product immediately. Health officials advise anyone who suspects exposure or observes these symptoms in an infant to seek medical care immediately.
Incident reported at 395 E St SW.
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Poisoned by our own country
@columbusUser1473038022 What do FDA regulations have to do with 4 retailers not pulling products off the shelf?!? Please connect those dots 🤔🙄
There need to be more regulations. There's 100 new recalls a week now
@fleurb Maybe gutting the federal workforce was a dumb idea.
i hope those babies turn out alright :(
@sandiegoUser1600063018 your mentality is what’s wrong with society
God protect the babies please 🙏🏾
@TravelingMan17 Choice is all ours.
Poisoned by our own country
@columbusUser1473038022 What do FDA regulations have to do with 4 retailers not pulling products off the shelf?!? Please connect those dots 🤔🙄
There need to be more regulations. There's 100 new recalls a week now
@fleurb Maybe gutting the federal workforce was a dumb idea.
i hope those babies turn out alright :(
@sandiegoUser1600063018 your mentality is what’s wrong with society
God protect the babies please 🙏🏾
@TravelingMan17 Choice is all ours.
Poisoned by our own country
@columbusUser1473038022 What do FDA regulations have to do with 4 retailers not pulling products off the shelf?!? Please connect those dots 🤔🙄
There need to be more regulations. There's 100 new recalls a week now
@fleurb Maybe gutting the federal workforce was a dumb idea.
i hope those babies turn out alright :(
@sandiegoUser1600063018 your mentality is what’s wrong with society
God protect the babies please 🙏🏾
@TravelingMan17 Choice is all ours.
Poisoned by our own country
@columbusUser1473038022 What do FDA regulations have to do with 4 retailers not pulling products off the shelf?!? Please connect those dots 🤔🙄
There need to be more regulations. There's 100 new recalls a week now
@fleurb Maybe gutting the federal workforce was a dumb idea.
i hope those babies turn out alright :(
@sandiegoUser1600063018 your mentality is what’s wrong with society
God protect the babies please 🙏🏾
@TravelingMan17 Choice is all ours.
Stay informed on local incidents
Download Citizen
Poisoned by our own country
@columbusUser1473038022 What do FDA regulations have to do with 4 retailers not pulling products off the shelf?!? Please connect those dots 🤔🙄
There need to be more regulations. There's 100 new recalls a week now
@fleurb Maybe gutting the federal workforce was a dumb idea.
i hope those babies turn out alright :(
@sandiegoUser1600063018 your mentality is what’s wrong with society
God protect the babies please 🙏🏾
@TravelingMan17 Choice is all ours.