In an update posted on the company’s website, ByHeart is warning its customers that “…all ByHeart formula across all product lots…” may be contaminated with Clostridium botulinum.
The warning comes after the company’s third-party testing lab (IEH IEH Laboratories & Consulting Group) found Clostridium botulinumin three out of three production lots. Five out of 36 samples tested were positive for the pathogen.
On November 11, 2025, ByHeart expanded an earlier product recall include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™. The recalled products were distributed on-line and nationwide across the United States, including Guam and Puerto Rico.
Information provided to the FDA by Amazon indicates that a limited quantity of recalled products also were distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and Virgin Islands.
As of November 19, 2025, the CDC reported 31 confirmed and suspected cases of infant botulism associated with consumption of ByHeart powdered infant formula. The affected infants range in age from 16 to 200 days.
In its communication to parents and caregivers, ByHeart has issued the following advice and information:
We want to reaffirm the critical direction for parents and caregivers to stop using ByHeart formula immediately. We continue to strongly recommend monitoring for symptoms of infant botulism and to contact a medical professional immediately if your child develops symptoms.
According to the American Academy of Pediatrics, the sign of Infant Botulism appears at an estimated 3 to 30 days from the time of consumption of the Clostridium botulinum bacteria.
Symptoms often begin with constipation followed by difficulty feeding (sucking and swallowing), a weak and altered cry, diminished facial expression, droopy eyelids, loss of head control, and lethargy.
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“Reads like a true crime novel” – Food Safety News
Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?
Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.
Food Safety Recall: MAMTAKIM Inc recalls BELEVINE brand DRIED WHOLE SMELTS SALTED (KORUSHKA) (5.29 oz (150 g); Expiration date 04/08/2026; Bar code 0754684898995) due to potential for growth of Clostridium botulinum.
Canada
Allergy Alert: Aux Saveurs des Sévelin inc. (Longueuil, QC) recalls various pâtés and tortières due to undeclared eggs.
Allergy Alert: Cuisine Régal inc. (Drummondville, QC) recalls various products due to undecalred wheat, soy, sulphites, eggs and milk.
Allergy Alert: Care Bakery Inc. recalls Care Bakery brand Cinnamon Buns (350g; All codes; UPC 8 57459 00038 5) due to undeclared egg.
Food Safety Recall: Alimentation Coop Rimouski (IGA Extra) (Rimouski, QC) recalls COMTOMME cheese (all lots) due to lack of labelling to indicate that the product was made from raw (unpasteurized) milk.
Food Safety Recall: Maître Saladier Inc. recalls Compliments brand Egg Salad (375g; Batch code 721722; Best before 2025NO27) and Forever Chef brand Egg Sandwich Filling (1.25 kg; Batch code 721713; Best before 2025NO27) due to spoilage.
Food Safety Recall: Exceldor Cooperative recalls Readyfoods brand Lean Ground Turkey with Natural Flavourings (2 x 2.5 kg; Batch code 41482; Best before 2026 06 19) due to foreign matter contamination (pieces of plastic).
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Ireland and United Kingdom
Allergy Alert (UK): Dimark Limited recalls Veira Dream of Angel Hair Pistachio Chocolate (165g; Batch codes 05052025 and 07042025; Best before 5 May 2026 and 7 April 2026) due to undeclared peanut and sesame.
Food Safety Recall (Ireland): Dunnes Stores recalls Dunnes Store Organic Porridge Oats (1 kg; Batch code 5284 FI; Time stamped between 06:00 and 12:00; Best before 11/10/2026; Product of UK) due to possible foreign matter contamination (clear plastic pellets).
Hong Kong and Singapore
No Alerts
Australia and New Zealand
Allergy Alert (Australia): Yummy Snack Foods recalls Yummy Fruit & Nut Barbi-Q Mix (400g; All Best before dates from 2APR2025 to 25NOV2025) due to undeclared cashew and milk, and Yummy Fruit & Nut Millionaires Mix (500g; All Best before dates from 2APR2025 to 25NOV2025) due to undeclared cashew, almond and macadamia
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“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.
“An invaluable resource for busy pet owners” – Food Safety News
eFoodAlert posts links to recalls for English-language countries only. If you are interested in recall information for other countries (including EU-member countries), please click on the Recall Link menu, above.
The live links in this post will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.
If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.
“Reads like a true crime novel” – Food Safety News
Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?
Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.
SWEDEN: Swedish National Food Agency and the Public Health Agency and partner agencies are investigating an outbreak of five cases of Hepatitis A virus, genotype 1A. All five victims reported having eaten frozen imported berries, strawberries, and raspberries, which were not heated before consumption.
United States
Allergy Alert: Prime Food Processing LLCrecalls Prime Food brand Lava Bun with Salted Egg Yolk and Prime Food brand Lava Bun with Green Tea Flavor (Lot Code Range: 25092-25318; Expiration Range: 07/26-03/27) due to undeclared milk.
Canada
Allergy Alert: Superior Meats recalls Superior Meats brand Premium Beef Jerky – Korean Smoked BBQ containing wheat (50g; Lot no. 2500994; UPC 1 86921 00099 9) due to misleading gluten-free claim.
Allergy Alert: Pastamore (Dollard-des-Ormeaux, QC) recalls JARDINIERE MAISON / Homemade sauce (All lots) due to undeclared sulphites.
Food Safety Recall: Chef à votre service (Montréal, QC) recalls Riz frit aux légumes / Vegetable fried rice (Best before 141125) due to possible Bacillus cereus contamination.
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Ireland and United Kingdom
Allergy Alert (Ireland): Trade recalls 1922 Viani Salumificio Salsiccia Toscana Al Peperoncino (300g; Batch code L12526508P; Best before 29/11/2025; Product of Italy) due to undeclared milk.
Allergy Alert (UK): Flapjackery recalls Flapjackery brand Mince Pie Crumble Flapjack products due to undeclared almonds.
Food Safety Recall (Ireland): Trade recalls Nutrilean Chocolate Brownie Overnight Oats (180g; Best before 25.11.2025; Product of UK) due to Listeria monocytogenes contamination.
Hong Kong and Singapore
Food Safety Alert (Hong Kong): CFS instructs the trade to suspend import of ByHeart powdered infant formula and urges travellers to immediately stop consuming the affected products if they have bought any of them.
Australia and New Zealand
Food Safety Recall (Australia): Götzinger Smallgoods recalls Various Sliced Ham and Meat products (1 kg; Multiple Use by dates) due to Listeria monocytogenes contamination.
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“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.
“An invaluable resource for busy pet owners” – Food Safety News
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