The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. 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. Abbott Recall | Powder Infant Formulas & 2 fl oz Ready-to-Feed Liquid Products, US - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort, Similac NeoSure, Pedialyte Electrolyte Solution, Canada - 1 lot of Pedalyte Electrolyte Solution; 1 lot of Similac Water (Sterilized), Puerto Rico, Bermuda, Curacao, Trinidad & Tobago, Jamaica - 1 lot of Similac 360 Total Care Sensitive, Puerto Rico, Curacao, Trinidad & Tobago, Barbados, Haiti, St. Thomas, St. Croix - 1 lot of Similac 360 Total Care, Panama - 2 lots of Similac Pro-Total Comfort, Dominican Republic - 1 lot of Similac Stage 1. 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. (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. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). 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. However, theyre still running out of formulas. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. Similac is among the most popular formula brands, but is it a healthy option for your baby? While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. 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. "We'll do whatever it takes to keep that trust and resolve this situation. 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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. Similac 360 Total Care Sensitive . Moms may have different reasons for choosing a particular formula for their babies. (21), Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee, explained that this will increase the FDAs staff so more of them can do the following: (21), However, this bill has been met with resistance, with other lawmakers such as Rep. Bill Huizenga saying that more formula production is needed, not more FDA staff. (37). 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. 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. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. Similac 360 Total Care Sensitive Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed for use for sensitive tummies as a milk-based alternative to standard milk-based formulas for sensitive tummies. Follow the directions in the email to reset your password. 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. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? Cronobacter infections are rare but can be especially dangerous for newborn babies. They established an IMG (Incident Management Group) to continue working on these supply chain and food safety issues as the out-of-stock rates soared to 43%. Enfamil NeuroPro Sensitive 19.5 oz . Similac and other formulas will be next in line once production starts. Safeguarding Infant Health during the Recall (47), Abbott explains that the nutrition formulas will be released free of charge to patients but on a case-by-case basis and in coordination with healthcare professionals. They havent confirmed how many formula units have been recalled. (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). This means you will no longer receive SMS notifications regarding Similac rewards or special offers. iPhone users should open in Safari. (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. (43). The case remains under investigation, with authorities still trying to determine the cause of the infants, Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of, Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for, Similac Recall February 2022 (First Recall), Similac recalls several powdered formulas for possible contamination that can cause, infection. 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. 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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. I am equally concerned that the FDA reacted far too slowly to this report. They can also find it from the list that the company later released. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. How many infants were fed contaminated formula during this time? (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. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. This voluntary recall only affected products sold in the Philippines. This recall does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. Many formulas from name brands like Similac are designed to closely resemble breast milk. Still, parents are also having trouble finding these products for their babies. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. The FDA had actually conducted plant inspections in September. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. It may cause a decrease in vitamin C levels over time. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. (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. Retail companies like Walmart have already put a cap on how many you can buy per transaction. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. They also need to promptly notify the FDA about the situation. (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. 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. 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. 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. (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. Contact the store or manufacturer for the refund or replacement process. The FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. (1). (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. (44), Updating the protocols for cleaning, water, and maintenance procedures, Upgrading the facility with the installation of sanitary floors that are easily cleanable and nonporous, Reviewing and updating their training system, education, and all safety procedures applicable for employees and visitors, White House Announces Measures For Formula Shortage, Cracking Down On Price Gouging & Unfair Market Practices, Abbott Nutrition Announces Release Of Some Products Amid Shortage, include the recently recalled Similac, Alimentum, and EleCare powder formulas. that first started with supply chain issues. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. (42). (62), Lot codes 40177RH and 40172RH, with a use by date of Nov. 1, 2007, The bottles lack a special layer that keeps air out. She added that buybacks were considered a form of manipulation and were illegal until 1982. Abbott voluntarily recalled one lot of Similac PM 60/40 with lot #27032K80 (can) or lot # 27032K800 (case) also manufactured in the companys facility in Sturgis, Michigan. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. (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. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. (20). Double-check the full product name, lot code, batch number, and the expiration or use by date. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. (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. If a product is included in the recall,do not use the product. The other reports were made from Ohio and Texas in the following months. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. It isnt ideal for premature infants or those with digestive and metabolic issues. . (29). (37). 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. (41)(42). (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. (40). (31). Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. Select Similac baby products are part of a new recall. Abbott Nutrition acknowledges their role in the infant formula shortage. (32), Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. Withdrawals, & After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. (10), The FDA announced that they received a report of another infant death last June 10. (19). (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). To find out if the product you have is included in this recall, click on the button below to check your lot number. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. 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. If yes, what happened, and which products were included? Aside from these two children, at least three babies have been hospitalized at the Medical University of South Carolina Shawn Jenkins Childrens Hospital in Charleston, South Carolina, due to intolerance after their parents or caregivers tried other formulas due to the shortage. 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. Key ingredients found in breast milk including 5 HMO prebiotics. Many parents are closely monitoring infant formula and baby food recalls because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. (3), Symptoms of sepsis and meningitis can include: (2). (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. Our formula also has nutrition designed for immune support, brain development, and digestive health. Why did it take four months to pull this formula off store shelves? (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. There wasnt any connection between their products and the four reported illnesses. Agriculture Secretary Tom Vilsack explained that this first batch can provide enough formula for around 9,000 babies and 18,000 toddlers for one week. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of Cronobacter sakazakii. If you still wish to opt-out, please click the button below to confirm. Consolidation Makes Formula Market Vulnerable, Reckitt Benckiser (Mead-Johnsons Enfamil), Making Food Safety A Priority To Avoid Repeat Of Formula Crisis, Babies Hospitalized Due To Formula Shortage, Two Children Hospitalized Because Their Specialty Formula Is Out Of Stock, Babies Hospitalized For Intolerance To New Formula & Mineral Imbalances, Undisclosed Number Of Children Hospitalized in Georgia, Undisclosed Number Of Kids Hospitalized in Wisconsin, Abbott Nutrition To Reopen Sturgis Plant Involved In Recall, According to Abbott Nutrition, theyll prioritize producing, and other formulas will be next in line once production starts. (48), DeLauro expressed alarm that the FDA didnt act quickly enough to check on the whistleblowers report, considering that it involves the possible unsafe production of infant formula. But with so many options available, even from the same brand, finding the right formula for your baby can be a huge challenge for many parents. 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. (4), Thats why theres also a shortage in the store brands like. It was the facility shut down in February following the massive Similac recall. The following are affected by this recall: (2). Retail companies like Walmart have already put a cap on how many you can buy per transaction. "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 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. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. The FDA clarifies that the recall is still in effect even though the investigation is closed. powder . Password reset email has been sent. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. (42). FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market It can even lead to an imbalance in your babys body that might cause their heart to stop. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. (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. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. Reckitt facilities can also operate at their maximum capacity following these shipments. 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. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : 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., Findings released by federal safety inspectors on March 22, 2022, show that Abbotts Sturgis, Michigan manufacturing plant involved in the recent Similac recall had several safety issues. (10), The agency announced that it will issue further guidance in September regarding how these companies could meet their requirements to continue supplying formulas beyond mid-November. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. 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. (28), However, Abbott denies that the buyback program hurt their products safety. Congressional leaders and various groups also want to hold the FDA accountable for whatever lapses or responsibilities it might have overlooked that led to the Abbott plant closure and baby formula shortage. 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. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. 235, 205, Dominican Republic: +1-849-200-1564, Haiti: 868-687-0223, Jamaica: 876-927-7098, Panama: 800-0410, St. Croix: 1(340) 690-7222, St. Thomas: 1(340) 690-7222, Trinidad & Tobago: 868-687-0223, Savings on Similac.com Schedule & Save purchases, Choose a preferred retailer, like Amazon or Target. This can result in spoilage. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. (56), The Similac recall involved dozens of different lots and products. 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. If a product is included in the recall, do not use the product. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. But it poses no immediate health risk of food poisoning. (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. (55), Batch no. The recall includes these 2 fl. (62), Lot 401895V, with a use by date of May 1, 2007, Similac Advance With Iron (Liquid Ready-To-Drink Formula), The formula bottles lack a special layer that keeps air out, leading to a possible chemical reaction between air and the formula that may decrease its vitamin C content. Minnesota health officials Califf reportedly sidestepped these questions by saying that its responsible for Americas baby formula shortage changes their... Leadership, saying that he cant share details of the babies formula also has nutrition designed for immune support brain... Or other inappropriate substitutions recall, then Similac PM 60/40 in the environment and a variety of around. They consumed the spoiled products Stage 1 ( formula for healthy babies ) can be especially dangerous for newborn.. Can check if your powdered formula is made with an exclusive blend of 5 HMO prebiotics structurally identical those., issuing the voluntary recall was the right thing to do because they didnt want risk... 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