A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility. There werent any new cases identified as part of the investigation. 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. What they're saying: "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," the company said in a statement. Find the answers below. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. 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. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. It is therefore important to verify the product lot number on the bottom or the side of the bottle. (37). (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. This can result in spoilage. (56), Call 800-986-8850 or visit similac.com/recall (the companys website for recalls), Similac Go & Grow Milk Early Shield Powder, When we identified this, we did extensive testing of every product on the (factory) line, and more than 99.8 percent of the product was negative for beetle contamination, , said Abbott spokeswoman Melissa Brotz. Inspect domestic and international suppliers. One of the cases was fatal. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. Follow the directions in the email to reset your password. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. The company assures consumers that they have improved their protocols and systems at the facility. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. (31). The baby had consumed Similac PM 60/40 from this lot. Abbott is voluntarily recalling these products after four consumer complaints related toCronobacter sakazakiiorSalmonellaNewport in infants who had consumed powder infant formula manufactured in this facility. The FDA relaxed some regulations to make it easier for foreign companies to import formulas to the US, while also assuring parents that these products meet US standards. 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. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. Before sharing sensitive information, make sure you're on a federal government site. 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. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. The .gov means its official.Federal government websites often end in .gov or .mil. (18), None of the DNA sequences in the FDA investigation matched the companys products. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. (21), Under this act, suppliers must prioritize orders from infant formula manufacturers before any of their other customers who may have ordered the same goods. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. (20), Bubs Australia at least 1.25 million cans of baby formula (22), UK manufacturer Kendal Nutricare (makers of Kendamil) around 100 trucks over the next six months (23), Abbott Needs To Comply With Court Consent Decree Before Production Can Resume, Hiring an independent third party expert who will review its processes, Cleaning and sanitizing the entire facility, including all equipment, Restarting all the equipment and completing test runs, Conducting multiple tests of all equipment, Abbotts Serious Steps To Address The Formula Shortage, Creating a $5 million fund for children hospitalized due to lack of access to specialized products, Converting production lines at their Columbus, Ohio, facility to prioritize the production of ready-to-feed liquid infant formula, Air-shipping millions of widely used powdered baby formulas from an FDA-approved plant in Ireland to the US, More than double the current production to help produce more products to address the shortage, Make significant investments to improve facilities to ensure the issue doesnt happen again, Invest in upgrading safety and quality processes and equipment, FDA Refutes Abbotts Claim Regarding Bacterial Strains, Groups Claim Abbott Enriched Shareholders While Plant Needed Repairs, Pelosi Eyes Criminal Charges Over Baby Formula Shortage, For Abbott Nutrition raw materials like sugar and corn syrup for infant formula, For Reckitt filters and other single-use products to generate certain oils needed in their infant formula production, Formula Makers Import European Stocks To Help With US Shortage. Our formula also has nutrition designed for immune support, brain development, and digestive health. During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. 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: Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. They havent confirmed how many formula units have been recalled. Many parents are closely monitoring infant formula and. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. Still, parents are also having trouble finding these products for their babies. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). 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. Recalled products can be identified by the 7 to 9 digit code and expiration date on. (37). The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. (13). hide caption. This investigation is ongoing. Similac is among the most popular formula brands, but is it a healthy option for your baby? (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. (29), Califf insisted that theres a need for major improvements at the FDA, not because people were bad but because they needed the right resources and consistent leadership. By opting-out, you are removing your phone number from your Similac profile. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (8), After a three-week shutdown following massive floods in the area, the Abbott plant in Sturgis, Michigan, has finally reopened again on July 1, 2022. (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. 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). However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. The following are some of the baby formulas recalled in 2021: These are imported products from Europe distributed by the online retail store LittleBundle website starting May 20, 2021. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. (45), As the formula shortage drove desperate parents to find online options, there were reports of products being offered on eBay for as high as $800, despite normally costing $43 to $47. Abbott Nutrition, which makes the Similac, Alimentum and EleCare brands, on Thursday issued a voluntary recall of certain formulas manufactured at its plant in Sturgis, Mich., where the formulas involved in the infections were produced. (18), Similac Pro-Total Comfort (Powder) infant formula, Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, Abbott Reopens Formula Plant, Starts EleCare Production, Some Global Companies To Send Formulas As US Shortage Hits 70%, rates continue to rise, with the number reaching as high as 70% in the week ending on May 22, according to a report from Datasembly. 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. Call Similac for refund processing or product replacement. ). They can also find it from the list that the company later released. Lax practices in terms of clean in place procedures, Failed to take corrective measures after knowing their testing procedures were deficient, Had an atmosphere of retaliation against employees who raised concerns about their company practices. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. ", Dunkin' fans heated over rewards program change, Time running out to claim child tax credits, stimulus checks, Florida orange crop declines after Hurricane Ian damage, Burger King adds spicy Ghost Pepper Whopper for Halloween, "If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.". Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. CNN Abbott Labs said Friday that it is recalling certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid formula for infants and children due to a problem with the bottle caps. At least two kids have been hospitalized in direct connection with the formula shortage. They havent confirmed how many formula units have been recalled. According to DeLauro, the whistleblower (name withheld for security reasons) wrote a 34-page report with a long list of allegations about security lapses and unsafe practices at the plant. (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. It was easier to increase the shipments because both were already being imported even before the shortage. Why did the FDA not spring into action? 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. The FDA had actually conducted plant inspections in September. (11). This 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. For many of these kids, finding the right formula can be a long, complicated process to make sure that it can meet their nutritional needs while also ensuring it wont trigger a potentially dangerous reaction, including dehydration or diarrhea. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. Similac powdered baby formula with an expiration date on or after April 1, 2022, and a code with first two digits of 22 through 37 and containing K8, SH or Z2 are part of a voluntary recall by its manufacturer, Abbott Nutrition. (20). It can even lead to an imbalance in your babys body that might cause their heart to stop. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. (1), Affected bottle and carton or case lot numbers in the US: (1), Affected lots with the same bottle and case numbers: (1), Bottle lot numbers only (no case lot numbers provided): (1), Carton or case lot numbers only (no bottle lot numbers provided): (1). If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Scott Stoffel, Abbotts spokesperson, confirmed that theyve been informed about the Justice Departments investigation and are cooperating fully. (7), It has been almost a year since the formula shortage crisis began in the US, yet it still persists despite efforts from the government and formula makers. (61). In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. (8), Reckitt Benckiser, the maker of Enfamil and now the US largest formula supplier, operates its formula factories 24/7 but believes that the crisis will persist until spring. FDA does not endorse either the product or the company. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. (21), The first two Defense Production Act authorizations are priority orders for Reckitt Benckiser (Mead-Johnsons Enfamil) and Abbott Nutrition: (31), Once the Abbott plant resumes operations, these priority shipments are expected to help increase their production by one-third. Similac issued three recall notices in 2022, involving multiple formula products. (36), A total of 192 Republican lawmakers voted against the bill, claiming that throwing millions of dollars at the problem wont fix it. (36), The Houses budget measure is expected to meet more resistance in the Senate. The following are affected by this recall: (2). 02.17.2022 - Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company's manufacturing facilities. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (31), The company representative added that theyre checking if they could tap into the Nestle global nutrition network for other formulas they could import after the FDA announced that companies are given temporary flexibility for importing baby formulas to address the shortage. It may cause a decrease in vitamin C levels over time. Theyre doing it to fulfill the FDAs request. (57), This voluntary recall included up to 5 million Similac powder infant formula units in plastic containers and 8-ounce, 12.4-ounce, or 12.9-ounce cans sold in the US, Guam, Puerto Rico, and some Caribbean countries. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. (48). As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. 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. (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. 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