Foster a culture of compliance to ensure they produce the highest quality baby formulas, Empower workers to identify and report issues that could compromise their products safety and quality. Photo: Stefani Reynolds / AFP via Getty Images. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. The baby had consumed Similac PM 60/40 from this lot. * Offers may vary. The US formula shortage 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. How many infants were fed contaminated formula during this time?, In a statement, Abbott Nutrition wrote that they: (50), Abbott claimed that they dismissed this former employee (the whistleblower) due to serious violations of the companys food safety policies. 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. (61). (55), Batch no. (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. 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. (48). (47), House Appropriations Committee Chair Rep. Rosa DeLauro announced that her office received alarming documents from a whistleblower who used to work at the Abbott facility that produced the recalled Similac formulas in February. Call Similac for refund processing or product replacement. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. 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). oz/59 ml ready-to-feed products: U.S. - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort . (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). 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. It is therefore important to verify the product lot number on the bottom or the side of the bottle. The site is secure. However, she warned that formula dilution can lead to organ failure or brain swelling. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : (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. (41), Jennifer Crouse, the Clinical Nutrition Manager of Childrens Wisconsin, disclosed that several children have also been admitted to their hospital or treated at the ER. Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (56), The Similac recall involved dozens of different lots and products. It was easier to increase the shipments because both were already being imported even before the shortage. These specialty formulas were prioritized because theyre in short supply in the US and serve a critical medical purpose for children with cows milk protein allergies. The FDA issued the recall advisory after four infants from three different states (MN, OH, and TX) fell ill after reportedly consuming Similac powdered infant formula produced in Abbott Nutritions Sturgis, Michigan facility. Abbott is continuing production of Similac 2 fluid ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers' offices on a different production line. This can result in spoilage. It was also quickly approved by the Senate and is now up to Biden to sign into law. Otherwise, click Cancel to return to your profile. The USDA (United States Department of Agriculture) is also coordinating with various states to let WIC recipients purchase whatever products are in stock instead of being limited to WIC-approved options. 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. One of the cases was fatal. (40), The two children (a toddler and a preschooler) were using EleCare, a specialty formula they needed because they both have short bowel syndrome and couldnt absorb full-size proteins. (4). Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. Cronobacter infection can be deadly, especially to newborns. 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 , (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". (9), The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. 03518QU (manufacturing date March 2019; expiration date March 2022). Some might feel more secure choosing a well-known brand name. (1), These products were distributed to some doctors offices, hospitals, distributors, and retailers in the US, Canada, Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, Jamaica, St Croix, Dominican Republic, Panama, Colombia, and Haiti. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. 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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (56), The recall was based on an internal quality review. The White House recently announced Operation Fly Formulas tenth flight to Fort Worth, Texas from Mexico, which will bring approximately 1 million pounds (equivalent to around 16 million 8-oz bottles) of Gerber Good Start Gentle infant formula. Affected customers were advised to search for the lot number of their item at similac.com/recall. Jaundice (yellow skin and whites of the eyes). The CDC (Centers for Disease Control and Prevention) announced on May 12, 2022, that it had closed the Abbott Nutrition investigation that linked the formula manufacturer to deadly Cronobacter infections. Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. 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. 2 fl oz ready-to-feed liquid products included in this voluntary recall: Its important to note that not all recalled products were distributed in all countries and not all 2 fl oz/59 ml formulas are included in the recall. On February 18, Abbott brand powdered infant formula products sold across the country have been flagged and recalled by the CIFA as there is the possibility of Cronobacter sakazakii and . This investigation is ongoing. However, theyre still running out of formulas. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Theyre now investigating the circumstances of the babys death. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. 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. Find the answers below. iPhone users should open in Safari. Abbott is continuing production of Similac 2 fluid ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers' offices on a different production line. Abbott Nutrition is recalling certain lots of ready-to-feed liquid baby products, including several under its Similac brand, for potential spoilage, the company said Friday. 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. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Call your pediatrician or doctor if your child shows signs of medical issues (such as stomach upset) from drinking the recalled product. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. But it poses no immediate health risk of food poisoning. Directions apply to Chrome onAndroid devices. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. At least two kids have been hospitalized in direct connection with the formula shortage. (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. that first started with supply chain issues. These products were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors, and some retailers in the US, including Puerto Rico; a limited number of products were sent to Canada, Colombia, the Dominican Republic, Panama, and certain countries in the Caribbean. As of press time, Abbotts Sturgis plant remains closed. (21), To prevent a similar shortage from happening again, the bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. (32), Some children with complex medical issues have been hospitalized for malnutrition at the Childrens Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. According to the hospital spokesperson, the kids ranged from babies to older children. 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. 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. (25), Abbott Laboratories CEO Robert Ford apologized for their role in the formula shortage, referring to the massive recall of Similac, Elecare, and Alimentum products in February 2022. (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. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (47). (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). Symptoms may include irritability with generalized tenderness. (28). Details: The recall is for 2 fluid ounce/59 ml bottles that were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors and some U.S. retailers, Abbott said. Withdrawals, & (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. Abbott Nutrition is recalling certain lots of ready-to-feed liquid baby products, including several under its Similac brand, for potential spoilage, the company said Friday. (39). Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. Experts point out that baby formula isnt subjected to the same high temperatures that other foods undergo to kill potentially deadly bacteria and other germs. The recalled products have been sold across the country. Key ingredients found in breast milk including 5 HMO prebiotics. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. The doctor explained that these kids didnt have other illnesses and could have stayed at home. Similac 360 Total Care Sensitive 30.2 oz. (2). Dr. Mark Corkins, a pediatric gastroenterologist at Le Bonheur Childrens Hospital in Memphis, Tennessee, revealed that he admitted two patients because their specialty formula is out of stock. (37). 360 Whole-Baby Support: Nutrition designed for immune support, brain development, and digestive health; Helps Strengthen the Immune System: Similac 360 Total Care is designed to help strengthen baby's immune system; Convenient & Ready to Use: Great for on-the-go and late-night feeding; no mixing required 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. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. Moms may have different reasons for choosing a particular formula for their babies. (37), Currently, 90% of the US formula market is dominated by just four players: (37), These four companies also dominate the federal contracts for the WIC program for low-income families, which accounts for 50% of US formula productions. It can even lead to an imbalance in your babys body that might cause their heart to stop. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness. Contains no artificial growth hormones and is non-GMO. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (13). (34), They have also increased production and worked round the clock to help meet the demand. bacteria, which caused serious infections. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 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 brandsSimilac Pro-Total Comfort, Similac360 Total Care, Similac360 Total CareSensitive, SimilacSpecial Care24, SimilacStage 1, SimilacWater (Sterilized), Similac NeoSure, and PedialyteElectrolyte Solution. (47), Whistleblower Reportedly Notified The FDA About Security Lapses Months Before Recall, Hid information during a 2019 audit by the FDA (Food and Drug Administration). They believe that having a leader in this position can unify and improve the FDAs food program. This means you will no longer receive SMS notifications regarding Similac rewards or special offers. Inspect domestic and international suppliers. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. Similac 360 Total Care Sensitive . But even if production starts again, Abbott explained that it could take at least 6-8 weeks before the products will be available for distribution. 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