January 27, 2023

ByHeart Infant Formula Powder Recalled For Possible Cronobacter

ByHeart Infant formula powder has been recalled for possible Cronobacter contamination. None of the distributed ByHeart products have tested positive for the pathogen. No illnesses or consumer complaints have been received to date. And this recall is not related to ByHeart's manufacturing facility that is located in Reading, Pennsylvania. The facility is running. Out of an abundance of caution, the company is recaling five batches of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months for potential cross-contamination with Cronobacter sakazakii. The formula is packaged in 24 ounce containers. The formula was distributed directly to consumers in the United States. You can identify the formula by the number that is stamped on the bottom of the can. … [Read more...]

Abbott Nutrition Recalls Ready to Feed Liquid Infant Formula

Abbott Nutrition is recalling certain bottles of ready to feed liquid infant formula because a small percentage of those products, which are less than 1% of the recalled amount, have bottle caps that may not have sealed properly. That could result in spoilage and could cause symptoms such as diarrhea and vomiting. The recalled product brands include Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. The products included in the recall were manufactured at the company's facility in Columbia, Ohio. The recall notice does not state whether or not any illnesses have been reported. The recall does not include ny other … [Read more...]

Mother’s Touch Baby Formula Recalled After FDA Warning

Mother's Touch Baby Formula has been voluntarily recalled after the FDA released a warning on September 16, 2022 that the product did not conform to the FDA's infant formula standards. This information was provided by Mother's Touch to retail consignees where the product was available for purchase at the retail level. The recall notice will be posted at a prominent location at these stores: Scenic Ridge Foods in Loganton, Pennsylvania; Hillside Bulk Foods in Gap, Pennsylvania; and Creekside Foods in Kinzers, Pennsylvania. The product was also available for purchase from the Mother's Touch web site. Mother's Touch is advising parents and caregivers who have unused containers of their formula to return them to the place of purchase. But the FDA is recommending that consumers who … [Read more...]

Similac Alimentum Infant Formula Recalled For Packaging Defect

Similac Alimentum Infant Formula is being recalled for a possible packaging defect. This recall notice was posted on the FDA's Enforcement Report web page on September 7, 2022, and is not on the usual FDA recall page, so we do not know if any adverse events have been reported to the company to date. The recalling firm is Abbott Nutrition of Columbus, Ohio. The recalled product is Similac Alimentum Infant Formula that is packaged in 32 ounce re-closable plastic bottles. There are eight bottles in each case, and about 720 bottles are included in this recall. The Batch/Lot Number that is stamped on each bottle is  41740RH00. The product number that is printed on the label is  57512 And the Best By date is 06/01/23 (June 1, 2023). This infant formula was distributed in Michigan and … [Read more...]

Do Not Feed Mother’s Touch Formula to Infants, Says FDA

Do not feed Mother's Touch Formula to infants, says the FDA. This product was marketed as an infant formula without the required pre-market notification to the FDA. And it does not meet infant formula nutrient requirements for seven nutrients. The FDA regulates infant formula very strictly. That agency has found that Mother's Touch Formula was not manufactured in compliance with the government's infant formula regulations. It has not been tested to see if it meets the requirements for this type of product, and it contains claims on the label for seven nutrients that do not meet the requirements. The consumption of this formula may cause nutrient deficiencies or toxicity in infants. In addition, this product was not fully tested for the presence of potentially harmful bacteria … [Read more...]

FDA Developing New Framework For Expanded Access to Infant Formula

The FDA is developing a new framework for expanded access to infant formula options for parents and caregiver in the wake of the Abbott Nutrition plant shutdown after Cronobacter contamination was found this spring. In May 2022, the FDA issued guidance that the agency was going to temporarily exercise enforcement discretion on a case-by-case basis for some requirements to address this shortage. The FDA has prioritized review of requests from firms that can document the safety and nutritional adequacy of their products, can make the largest volume of product available, and can get their products onto shelves in this country quickly. The infant formula supply has dramatically increased in the weeks since that guidance was issued. Many infants and other people rely on infant formula … [Read more...]

FDA Alert on Plug Heist Trap House Homemade Infant Formula

The FDA has issued an alert on Plug Heist Trap House oh baby homemade infant formula. This product was not manufactured in compliance with infant formula regulations and was not tested to ensure it meets the strict nutritional requirements for infant formula. The company also did not submit the required pre-market notification to the FDA, as required by law. It's important to note that homemade infant formulas have not been evaluated by the FDA for safety and may lack nutrients that are vital to their growth. The FDA conducted an investigation at the firm's location, which is a home residence. The formula was made with astragalus root, elderberry, echinacea, organic apples, organic carrots, cat nip, sea moss, bananas, hemp, soursop, chamomile, and oatmeal. It claims to be dairy … [Read more...]

Senator Murray Wants Answers on Alleged Food Safety Failures

Senator Patty Murray (D-WA) wants answers on alleged FDA food safety failures after a report in Politico listed problems with that agency. Senator Murray is Chair of the Senate Health, Education, Labor, and Pensions Committee. A letter was sent to FDA Commissioner Robert M Califf, asking for answers and immediate action. The Politico report was based on more than 50 interviews with experts and former officials and found that the FDA is more focused on regulating and overseeing drugs and other medical products than food. For instance, FDA commissioners rarely have experience with food issues, but are usually medical doctors. The report lists deadly food poisoning outbreaks and the recalls associated with the contaminated foods, starkly outlining how long it can take to issue a recall … [Read more...]

FDA Update on Similac Cronobacter Investigation Reveals No Match

The FDA has updated the Similac Cronobacter investigation  and reports that there is no match between the environmental samples of Cronobacter found at Abbott Nutrition's Sturgis, Michigan plant and the two patient samples the CDC received and tested. In all, four infants were sickened with Cronobacter infections after allegedly consuming powdered infant formula produced by Abbott Nutrition. Two infants who lived in Ohio died, although the FDA has not determined if Cronobacter had a role in those deaths. The FDA states, "Five environmental subsamples collected from the Sturgis, Michigan facility were positive for Cronobacter sakazakii; four were detected by the FDA and one was detected through firm-initiated testing. The positive Cronobacter sakazakii environmental samples at the … [Read more...]

CDC: Two Cronobacter Samples Not Closely Related to Swabs From Abbott

The CDC has found that two Cronobacter samples from infants are not closely related to environmental swabs that were taken by the FDA from the Abbott Nutrition facility in Michigan. Powdered infant formulas that have since been recalled were produced at that venue. This update, published on March 25, 2022, also found that bacteria from the two available samples are not closely related to each other. These conclusions come from whole genome sequencing conducted on the samples. FDA analysis is ongoing, and there is no word on whether or not samples from the other two patients have been analyzed with whole genome sequencing (WGS). The government is still recommending that parents not feed their infants recalled powdered formula made at that Michigan plant. The formula types that are … [Read more...]

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