This can result in spoilage. At least two kids have been hospitalized in direct connection with the formula shortage. Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility. Recalled products can be identified by the 7 to 9 digit code and expiration date on. The following are affected by this recall: (2). (38), To meet the demands, Enfamil production has been increased to 30%, the company added. bacteria, which caused serious infections. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. (60), According to the FDA, premature babies fed with this formula for over a month may have a higher risk of developing iron-deficiency anemia because of insufficient iron intake. President Joe Biden had previously directed various agencies to import products from companies overseas that meet US standards using military planes through Operation Fly Formula. (21). . (26), Abbotts head detailed the serious steps the company is taking to address the baby formula shortage: (26), Once the production resumes at Sturgis, Michigan, Ford detailed that they will do the following: (26), While Abbott maintains that the strains from the FDAs investigations dont match those taken from their facility, FDA officials recently refuted this claim. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to, Similac, Alimentum, and EleCare powdered infant formulas, The code at the bottom of the package or container contains K8, SH, or Z2, The first two digits of the code are numbers from 22 to 37, The expiration date code is 4-1-2022 (APR 2022) or later. (45), The White House released the additional measures they will follow to increase the formula products available without compromising babies safety: (45), The US typically produces nearly all (around 98%) of the infant formulas it needs. Crouse said that the exact number of children hospitalized relating to the formula shortage isnt available, but its apparent that theyve had several of these admissions. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands SimilacPro-Total ComfortTM, Similac360 Total Care, Similac 360 Total Care Sensitive, SimilacSpecial Care24, Similac Stage 1, SimilacNeoSure, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. From December 1, 2021, to March 3, 2022, the FDA reportedly received a total of nine reports of formula-related baby deaths, with two among the four confirmed Cronobacter sakazakii infections that led to the February 2022 Similac recall. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. The recalled products have been sold across the country. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands Similac Pro-Total Comfort TM, Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure , RECALL NOTICE: OUTSIDE US October 2022 Abbott is initiating a proactive, voluntary recall of certain lots of 2 fl oz/59 ml bottles of Ready-to-Feed liquid products, including the brands Similac Pro-Total Comfort , Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac Water (Sterilized), Similac Neosure and . Abbott Nutrition issued a voluntary recall of certain lots of ready-to-feed liquid products (2 fl oz or 59 ml bottles), produced at their manufacturing facility in Columbus, Ohio, due to a manufacturing defect. According to the recall advisory, products from Abbott Nutritions Sturgis, Michigan facility have been distributed across the US and likely to have been exported to other countries. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. But it poses no immediate health risk of food poisoning. Affected customers were advised to search for the lot number of their item at similac.com/recall. Affected products have a code beginning with first two digits of 22 through 37 and containing K8, SH or Z2 and have an expiration date of April 1, 2022, or later. If you still wish to opt-out, please click the button below to confirm. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. Why it matters: About 3 in 4 babies are fed formula by six months old as a complete or partial substitute for human milk, Axios' Nathan Bomey reports. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. Failure to establish a system of process controls that covers all stages of processing to ensure that baby formula doesnt become contaminated due to the presence of microorganisms (e.g., bacteria) in the formula or in its processing environment. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (15), 686,350 cans equivalent to approximately 16.5 million 8 fl oz bottles of Similac NeoSure (for premature babies or low birthweight infants) and Similac Total Comfort (for infants with sensitive tummies) will be imported by Abbott from their manufacturing facility in Granada, Spain, starting in June and throughout the summer. Similac and other formulas will be next in line once production starts. Directions apply to Chrome onAndroid devices. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . Nine Baby Deaths Reported During FDA Investigation, From December 1, 2021, to March 3, 2022, the FDA reportedly received a total of nine reports of formula-related baby deaths, with two among the four confirmed, infections that led to the February 2022 Similac recall. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport. (1). Liquid baby formula and all other products produced by Abbott Nutrition are not affected. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. White House National Economic Council director Brian Deese said that the Air Force cargo plane carried 15% of the specialty medical-grade baby formula needed in the US. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. 02.17.2022 -Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentumand EleCare,manufactured in Sturgis, Michigan, one of the companys manufacturing facilities. Cronobacter infections are rare but can be especially dangerous for newborn babies. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. Before the massive Similac recall, Abbott Nutrition topped the market spot with 40% of the market share, closely followed by the long-time number 2 player in the US, Enfamil. Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands 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 massive recalls worsened the formula shortage in the US that first started with supply chain issues. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. The action comes after learning of the death of an infant who tested positive forCronobacter sakazakiiand who we were informed had consumed Similac PM 60/40 from this lot. (1), ByHeart Whole Nutrition Infant Formula Recall, The Similac Recall & The Formula Shortage (2022), in the US, worried parents are having difficulty finding supplies for their babies. Some brands have very similar packaging for different types of formula. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. (55), Batch no. During a May 2022 bipartisan hearing, Rep. Rosa DeLauro and other lawmakers repeatedly asked the FDA head why the agency took several months to investigate a whistleblower complaint on safety violations at Abbotts plant. Previous investigations by the FDA (Food and Drug Administration) reportedly discovered several violations, including Abbotts lax safety protocols and bacterial contamination at its manufacturing facility. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. Heres the statement from Abbott regarding this recall: Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility. These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. In particular, this measure will let WIC participants buy any formula from any available supplier rather than be limited by the unavailable WIC-approved brand. (11), According to the FDA, the infant death reportedly happened in January. The products included in the recall were distributed primarily to hospitals and to some doctors offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. ). (18), None of the DNA sequences in the FDA investigation matched the companys products. during the first recall, then Similac PM 60/40 in the second recall. Designed to support the immune system, brain development, and digestive health. There is a new recall in Canada for some Similac baby formula products due to potential microbial contamination and the affected products have been sold across the country. Abbott Recalls Ready-to-Feed Liquid Products, 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti), 40561N200 (also sold in Puerto Rico, Curacao, Jamaica, Bermuda, and Trinidad & Tobago), 40749N200 sold in the Dominican Republic, 39398N200 (bottle lot number only) sold in Canada, Similac Recall February 2022 (Second Recall), This recall was done after the death of another infant who tested positive for. Many parents also consider the following European formulas as the best organic options for their babies: Please consult your healthcare provider before switching to these formulas. Similac 360 Total Care Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed to support the immune system, brain development and digestive health. (1). FDA Details Safety Issues At Abbott Plant Linked To Formula Recalls, Failure to maintain the sanitary conditions of surfaces used to prepare and handle formula, bacteria contamination between fall 2019 and February 2022. (56), The recall was based on an internal quality review. Meanwhile, Abbott said the recall "equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply.". To identify if your product is included, please visitsimilacrecall.comto view a list of impacted lot numbers or use the lot number checker on the webpage. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. A review of the firms internal records also indicate environmental contamination with Cronobacter sakazakii and the firms destruction of product due to the presence of Cronobacter. (2), Cronobacter can cause severe, life-threatening infections such as sepsis or meningitis (inflammation of the membranes protecting the brain and spine), according to the CDC (Centers For Disease Control And Prevention). (46), Retailers like Target, CVS, and Walmart have since put a cap on the number of formula packs that consumers can buy online and from their stores. Recalled: Similac Formulas Manufacturer's Recall Notice FDA Recall Notice sold at: Target Stores and Target.com recall date: 2/17/2022 Recall Description For more specific information regarding this recall, visit the government agency or manufacturer website: Product Recall Details Target Item Number: Before sharing sensitive information, make sure you're on a federal government site. Thankfully, the children have all been discharged. Contact 1800-10-995-1555 (Province), (02) 995-1555 (Manila), or, Several powdered baby formula products were recalled due to the remote possibility of contamination with larvae, full-grown adults, or insect parts of the small common beetle. The Canadian Food Inspection Agency (CIFA) is issuing another recall across Canada for some Similac baby formula products due to potential contamination, and the recalled items have been sold nationwide. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. Affected lots (same bottle and case numbers): Bottle lot numbers only (no case lot numbers provided): Abbott Nutrition clarifies that the recall only affects these products and specific lot or case/carton numbers. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. 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