The FDA, CDC, California Department of Public Health and state and local partners are investigating a ten-state outbreak of infant botulism that has sickened 13 infants so far.
Caregivers for all thirteen infants reported feeding ByHeart Whole Nutrition infant formula.
Illnesses have been reported in Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). These totals include both suspected and confirmed cases.
The thirteen victims range in age from 16 to 157 days. All thirteen have been hospitalized and treated with BabyBIG®, an antidote to infant botulism.
Several states have collected leftover samples of infant formula for testing; work is in progress, but the results are not yet available.
The FDA has recommended that the manufacturer, ByHeart Inc., initate a recall. The company has complied and is recalling the following two lots, which were reported to have been consumed by the infants:
ByHeart Whole Nutrition Infant formula:- Lot no. 206VABP/251261P2 and Lot no. 206VABP/251131P2)
What consumers and caregivers need to know
How to identify infant botulism
Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinuminfects a baby’s large intestine and make toxin in it.
Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone. Symptoms can progress to difficulty breathing and respiratory arrest.
Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.
What actions to take
Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.
Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.
If you are a Physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.
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Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.
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FOOD SAFETY INVESTIGATION UPDATE: FDA is conducting an onsite inspection at the Austrofoods facility located in Ecuador, including collection of cinnamon samples for lead testing. The agency has received reports of 65 adverse events to date, potentially linked to Cinnamon Applesauce Products manufactured in Ecuador.
OUTBREAK INVESTIGATION UPDATE: CDC reports a total of 80 lab-confirmed Salmonella illnesses linked to consumption of Gill’s Onions brand Fresh Diced Onions. One person has died, and 18 were hospitalized. The outbreak is now over, according to the federal agency.
Allergy Alert: Bobo’s recalls Bobo’s Peach Oat Bars (3-oz bars; Lot 3J21111 or 3K01111; Best by 7/17/2024 and 7/28/2024, respectively; UPC 829262000203) due to undeclared coconut.
Public Health Advisory: FDAadvises consumers not to eat, and restaurants and food retailers not to sell, and to dispose of Red’s Best chopped clams likely harvested from prohibited waters in Massachusetts (Lots #331 and #333; Shuck dates 23/331 and 23/333) because they may be contaminated with human pathogens, toxic elements or poisonous or deleterious substances.
Food Safety Recall: WS Global, INC recalls Himalayan Pain Relief Tea (6 tea packets/box; All lots; Bar code 0841920015) due to presence of hidden drug ingredients, Diclofenac and Dexamethasone.
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Canada
Food Safety Recall: Dans Mon Bocal Ste-Adèle inc. (Sainte-Adèle, QC) recalls BICARBONATE DE SOUDE / Sodium bicarbonate (Bulk; Sold from 30 October to 12 December 2023) due to mislabeling. The product is actually sodium percarbonate, a strong irritant.
Europe
Allergy Alert (Germany): Nadi Holding GmbH recalls Grüne Rosinen extra lang / Extra long green raisins (400g; Best before 01.06.2025) due to undeclared sulphur dioxide.
Allergy Alert (Germany): Nadi Holding GmbH recalls Aprikosen Chapa Namak / Salted apricots (400g; Best before 31/12/2024) due to undeclared sulphur dioxide.
Allergy Alert (Iceland): Ósnes ehf recalls Karrísíld / Curry chicken (2.25 kg; All lots) due to undeclared egg and mustard.
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Food Safety Recall (Belgium): Carrefour recalls Carrefour Classic brand Fond de Boeuf / Beef stock (190 ml; Lots 23058 301 & 23058 201; Best before 28/02/2026) due to possible foreign matter contamination (pieces of glass).
Food Safety Recall (Denmark): Nestlé Danmark A/S recalls NAN EXPERTPRO HA 1 modermælkserstatning / Infant formula (Batch code 33120742C2; Expiry date 11/2025) due to a risk of Cronobacter sakazakii in one of the raw materials included in the product.
Food Safety Recall (France): Industry recalls Maison Prunier brand Galantine de Volaille / Poultry galantine (Lot 296292; Use by 15/12/2023) due to Listeria monocytogenes contamination.
Food Safety Recall (France): ATELIER FOREZIEN DU FRAIS recalls AFFRAIS brand SAUCISSE SECHE SACHET / Dry sausage (Lot 338/9003; Use by 02/02/2024) due to Salmonella contamination.
Food Safety Recall (France): ATELIER FOREZIEN DU FRAIS recalls DESPI LE CHARCUTIER brand SAUCISSE SECHE PP VPFSACHET / Dry sausage (Multiple lot codes and use-by dates) due to Salmonella contamination. Please refer to the recall notice for a complete list of affected products.
Food Safety Recall (France): Manufacturer recalls multiple lots and varieties of cheeses due to shiga toxin-producing E. coli contamination. Please refer to the master recall notice for a complete list of affected products.
Food Safety Recall (France): RENE MEYER SARL recalls multiple Volailles René MEYERproducts due to insufficient process control that could result in food safety hazard. Please refer to the Rappels Conso page for a complete list of affected products.
Food Safety Recall (France): DELBE TRAITEUR recalls Hachis de viande nature / Unseasoned ground meat (Lot 06122023) due to Salmonella contamination.
Food Safety Recall (France): PRESTIGE DE LA SARTHE recalls prestige de la sarthe brand jambon persille de bourgogne / Parsleyed ham (1.5 kg & 9 kg; Lot 43298; Use by 15/12/2023) due to Listeria monocytogenes contamination.
Food Safety Recall (France): CARREFOUR FRANCE recalls Carrefour SIMPL brand Queues de crevettes crues avec carapace / Raw shrimp tails, with shell (450g; Lot AI/22204 (3A06); Best before 05/01/2025) due to Vibrio vulnificus contamination.
Food Safety Recall (France): CORA recalls cora brand Saumon fumé Norvège / Norwegian smoked salmon (210g; Lot G3380374P; Use by 03/01/2024) due to Listeria monocytogenes contamination.
Food Safety Recall (France): BROCELIANDE recalls GRAL and unbranded Rouleau de mousse de canard au Porto de Qualité supérieur / Superior Quality duck mousse roll with Port (Lot 1217857; Best before dates between 20/01/2024 and 22/01/2024) due to possible Listeria monocytogenes and/or Salmonella contamination.
Food Safety Recall (Sweden): Axfood recalls Garant brand Strimlad rökt skinka / Shredded smoked ham (180g & 450g; Best before 2023-12-29) due to possible Listeria monocytogenes contamination.
Asia, Africa and the Pacific Islands
Allergy Alert (Hong Kong): NGAR YAT IND CO LTD recalls NEW MOON BRAND FRESH BEAN CURD STICKS (200g; Use by April 25, 2024; Product of China) due to undeclared sulphur dioxide.
Allergy Alert (Israel): A.L. Production and Marketing of Spices Ltd. recalls Tablini Maimon brand Seasoning Mixture for Steak (100g; Batch code 166565; Best if used before end 02/2025) due to undeclared peanut.
Australia and New Zealand
Allergy Alert (Australia): Stuart Alexander & Co Pty Ltd recalls Hershey’s Caramel Syrup (623g; Best before 08 2025) due to undeclared milk.
Allergy Alert (New Zealand): New World Remuera recalls Clonbern Kitchen brand Truffle & Parmesan Flavour Made in Store Beef Sausages (Best before 29.08.23 up to and including 18.12.23) due to undeclared gluten (wheat) and soy.
“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.
In response to the infant formula supply crisis in 2022 and the deadly infections that led to it, the FDA has updated its infant formula compliance program.
An outbreak of Cronobacter infections in five infants, two of whom died, started in the fall of 2021 and stretched into early 2022. Abbott Nutrition initiated a recall of Similac infant formula powder and other brands in February 2022. The recall led to a nationwide shortage and left parents driving for hours in search of formula for their babies.
During its investigation, the Food and Drug Administration found Cronobacter contamination in Abbott’s production plant in Sturgis, MI. The agency also discovered that the company had tested product and received positive outcomes for Cronobacter, which Abbott had not reported to the FDA.
In May 2022, after grueling congressional hearings, FDA officials launched an internal investigation that included review of issues raised by a whistleblower complaint. The new compliance program is in response to that investigation. The program covers FDA investigators, laboratory analysts, and compliance officers.
“The infant formula compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious,” according to a statement from FDA.
“The FDA has now published its updated compliance program, which builds on lessons learned over the last several years to elaborate on our approaches for inspections, sampling, laboratory analysis, and imported infant formula products.”
Going forward, to be in compliance entities must follow updated instructions for annual environmental sampling at powdered infant formula production facilities. Those sampling tests must include Cronobacter and Salmonella. If testing shows either of the pathogens the FDA must be notified. The agency also must be notified if testing shows nutrients that are above or below required levels per the FDA’s infant formula regulation.
The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program at the Food and Drug Administration.
Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program.
In addition, it further elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022.
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