Some options for you to try (US brands), with your pediatricians approval: *Check out our interviews with Serenity Kids founders on their toddler formula, and their baby food pouches. 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. (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. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. (37). 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. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. Reckitt facilities can also operate at their maximum capacity following these shipments. If a product is included in the recall, do not use the product. 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. The company assures consumers that they have improved their protocols and systems at the facility. It isnt ideal for premature infants or those with digestive and metabolic issues. But there were no serious medical complaints reported concerning this Similac recall. The first recall (Similac, Alimentum, and EleCare powdered infant formulas) was issued on February 17 due to possible contamination with Cronobacter sakazakii bacteria, which caused serious infections. Before sharing sensitive information, make sure you're on a federal government site. (26), Since Abbott has over 40% share of the US infant formula market, their formula recall and subsequent plant shutdown badly affected the formula supply. (41)(42). (42). (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. . Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. 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. Understanding the need for the international community to help solve the US crisis as more babies go hungry, several foreign baby formula companies offered to help. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. The baby had consumed Similac PM 60/40 from this lot. The whistleblower alleged that Abbott Nutrition: (48), The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. Abbott Nutrition said it is cooperating with the FDA investigation into the three Cronobacter sakazakii infections and one salmonella infection, all of which required hospitalization. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. (50). Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. 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 recalled products have been sold across the country. (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. Some might feel more secure choosing a well-known brand name. 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. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. (1). (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. (5)(43), After getting involved in the massive Similac recall in February 2022, Abbott Nutrition recently announced that it plans to reopen the Sturgis, Michigan plant in about two weeks. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: Join Similac Rewards for up to $400*in benefits and support throughout your journey. (11). Top FDA Official Resigns Over Formula Shortage, Abbott Under Criminal Investigation Over Possible Role In Baby Formula Shortage, Enfamil Maker Believes Shortage Will Last Until Spring, FDA Plans To Allow Overseas Formulas Beyond Shortage, FDA Investigates Another Abbott Formula-related Baby Death, Newly Reopened Abbott Plant Shuts Again Due To Floods, After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the, 95,000 cans arrived in LAX for Walmart, Albertsons Companies, and The Kroger Company grocery stores from Australia. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. Yes, but: Lot numbers of the affected products are listed at First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. Contact the store or manufacturer for the refund or replacement process. 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.". (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. 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. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. Theyre now investigating the circumstances of the babys death. Republicans are questioning why the FDA isnt held accountable for the shortage and the possible lapses that led to the deaths of the two babies linked to the Abbott products. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. Update password per the new system standards (8 Characters). This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems. 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. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (38), During the hearing before the House subcommittee, Califf asked lawmakers to increase the agencys budget from last years $2.1 billion to $8.4 billion for food safety and nutrition. Formulas still to arrive starting in June or July: The CFIA (Canadian Food Inspection Agency) warned consumers who bought from Shoppers Drug Mart to check their products after the retail pharmacy giant accidentally sold recalled baby formulas from Abbott due to an online error. (17). (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. (21), Abbott reportedly enjoyed profits soaring as high as 94% between 2019 and 2021 even as bacteria was detected in its products during the same period. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. 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. The baby reportedly consumed formula made by Abbott Nutrition. 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. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. 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. Two House bills were passed to address the shortage. powdered infant formulas) was issued on February 17 due to possible contamination with. To identify if your product is included, please visit to view a list of impacted lot numbers or use the lot number checker on the webpage. 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. (12), These flights will arrive starting on June 24. 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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. This can result in spoilage. (35), Republican House representatives filed a counter bill they call the Babies Need More Formula Now Act which aims to obtain formulas from overseas sources. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Call Similac for refund processing or product replacement. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. (32). Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. (51)(52), The FDAs preliminary findings show the following: (51)(52), The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. 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 FDA had actually conducted plant inspections in September. However, even with the plants reopening, Abbott Nutrition estimates that the new products will only reach the store shelves in around six to eight weeks. (57)(58), No liquid formula products were included in this recall. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. So, major disruptions of these companies supplies, such as a massive recall like the February 2022 Similac recall, can greatly affect the formula supply in the market. (28), Also, she believes that restrictions should be imposed on companies that receive federal funding or in Abbotts case, companies whose largest customers are federal programs such as the WIC. Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. Moms may have different reasons for choosing a particular formula for their babies. There wasnt any connection between their products and the four reported illnesses. 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. More are expected to arrive on three more flights in the coming weeks. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. (33)(35), This is significant because the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children) accounts for as much as 50% of infant formula sales in the US. (2)(3). The recall does not include any metabolic deficiency nutrition formulas. (7). (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. (61). These were the same products recalled in February 2022 and had the following codes (found at the bottom of the package or container): The store is once again recalling these recalled infant formulas, which shouldnt have been sold back to consumers at all. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. Federal inspectors found several safety violations: (43)(51)(52). 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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. Theyre doing it to fulfill the FDAs request. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. Similac 360 Total Care Sensitive 30.2 oz. 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. The FDA clarifies that the recall is still in effect even though the investigation is closed. (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. (56), The recall was based on an internal quality review. 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. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. 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. (16), Recalled Baby Formula Accidentally Sold In Canada, The first two digits are numbers from 22 to 37, The expiration date code starts from 4-1-2022 (APR 2022) and subsequent dates. Affected customers were advised to search for the lot number of their item at 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. . Instead, these products were those put on hold amid the recall. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". (4). This investigation is ongoing. 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. It was easier to increase the shipments because both were already being imported even before the shortage. ". 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. I am equally concerned that the FDA reacted far too slowly to this report. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. (38), To meet the demands, Enfamil production has been increased to 30%, the company added. (13), 750,000 cans of Danone formula, which is equivalent to 19 million 8-ounce bottles, will arrive from their manufacturing facility in Ireland in July. (16), 44,000 pounds (equivalent to approximately 548,000 eight-ounce bottles) of specialty infant formulas Nestl Health Science Alfamino and Alfamino Junior arrived at the Louisville International Airport from Switzerland. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (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. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. Some of the companies that offered to help: A consent decree filed at the US District Court for the Western District of Michigan created a legally binding agreement between Abbott and the FDA, with steps that the company had to comply with before production at the Sturgis facility can resume. 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. As of press time, Abbotts Sturgis plant remains closed. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (28), However, Abbott denies that the buyback program hurt their products safety. Call your pediatrician or doctor if your child shows signs of medical issues (such as stomach upset) from drinking the recalled product. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. According to the hospital spokesperson, the kids ranged from babies to older children. ", What's next: The company said it 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. Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. (28). The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (29), This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. 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. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Abbott Voluntarily Recalls Certain Lots of 2 Fl. (7), It might have played a big role in the shortage and can be held liable, depending on the outcome of the Justice Departments investigation. She added that buybacks were considered a form of manipulation and were illegal until 1982. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? Federal inspectors found several safety violations: Some employees failed to sanitize their hands. Otherwise, click Cancel to return to your profile. 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). Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. 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. 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. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. But something must be done to correct this serious safety concern. 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. If you still wish to opt-out, please click the button below to confirm. We found no evidence ofSalmonellaNewport. 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. Follow the directions in the email to reset your password. (2). According to Dr. Corkins, the preschooler has been admitted since April and remains at the hospital, while the toddler was only hospitalized for about a week. Similac infant formula will be produced in "alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network," Abbott said. Key ingredients found in breast milk including 5 HMO prebiotics. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. (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). 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), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. Latest News: Voluntary Recall of 2 fl oz Ready-to-Feed Liquid Products, U.S.: +1-800-986-8540, Puerto Rico: +1-787-622-5454, Barbados: 246-417-0777, Bermuda: 279-5568, Canada: 1-855-733-4201, Colombia: 1-800-518-9379, Curacao: 737-2222 Ext. Food safety advocates are furious over how the FDA and Abbott handled these safety issues, especially because their lapses may have caused the death of at least two babies. 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. (48). Find the answers below. (11), According to the FDA, the infant death reportedly happened in January. (39). Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. 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.

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