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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. (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. 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. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. 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. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. 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. (53), These products are affected by the recall: (54), This infant formula recall included these Similac products: (57)(58), According to the FDA (U.S. Food and Drug Administration) recall notice, ingestion of the larvae or beetle could cause intestinal discomfort, and the child might refuse to eat. (56), It affected products made at a plant in Sturgis, Michigan. For all feeding-related questions or questions about your childs health, contact a healthcare professional. (47). The baby reportedly consumed formula made by Abbott Nutrition. (44). 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. . Then, theyre marking these up for online retail at exorbitant prices. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Password reset email has been sent. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. (13). Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. * Offers may vary. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". So, Abbott includes this specialty product in the items being released along with these metabolic products: (47), Abbott assures consumers that these products have been tested, werent included in the recall, and comply with all the product release requirements before distribution. 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. 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. 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), According to the recall advisory, these are the affected products: (1), Abbott Nutrition clarified that only a small percentage of bottles might have been affected by the manufacturing defect. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. 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 . 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. If a product is included in the recall, do not use the product. I am equally concerned that the FDA reacted far too slowly to this report. during the first recall, then Similac PM 60/40 in the second recall. (34), They have also increased production and worked round the clock to help meet the demand. (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. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. Call your pediatrician or doctor if your child shows signs of medical issues (such as stomach upset) from drinking the recalled product. They havent confirmed how many formula units have been recalled. 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 FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market Withdrawals, & 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. 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. (1). She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. (28), Two years before the recall, Abbotts net profits increased from $3.6 billion to $7.1 billion, according to Securities and Exchange Commission records. Heres the statement from Abbott regarding this recall: Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. 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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. They can also find it from the list that the company later released. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to, Similac, Alimentum, and EleCare powdered infant formulas, The code at the bottom of the package or container contains K8, SH, or Z2, The first two digits of the code are numbers from 22 to 37, The expiration date code is 4-1-2022 (APR 2022) or later. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. 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. (56), The recall was based on an internal quality review. Senate To Investigate Abbotts Safety Improvements & Buyback Program, The Senate Finance Committee recently announced through Senator Ron Wyden that theyre going to investigate Abbotts investments in their plants safety improvements amid record revenues. (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. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (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. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. Some might feel more secure choosing a well-known brand name. Enfamil NeuroPro Sensitive 19.5 oz . (42). (31), The White House further announced that the first round of flights will carry a total amount of formula equivalent to 1.5 million doses of eight-ounce bottles. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. It also does not include any amino acid-based formulas or metabolic nutrition formulas. (20). (2). (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. 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. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. (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. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". Why did the FDA not spring into action? (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (31), However, these specialty formulas arent expected to hit retail store shelves. 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. 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. 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 manufacturing defect may cause a decrease in the formulas vitamin C content over time. Reckitt facilities can also operate at their maximum capacity following these shipments. (30), Although she called the shortage unconscionable and tragic, Pelosi didnt specify the details of the possible indictment. However, she clarified that her remarks about the need for criminal charges arent associated with any of her colleagues. Otherwise, click Cancel to return to your profile. 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. Update password per the new system standards (8 Characters). Contains no artificial growth hormones and is non-GMO. (30), She further explained that its important to solve the problem as soon as possible. (48). 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. 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 Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . 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. (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. It was easier to increase the shipments because both were already being imported even before the shortage. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. The other reports were made from Ohio and Texas in the following months. 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. 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. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. 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 is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. (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. Key ingredients found in breast milk including 5 HMO prebiotics. If you still wish to opt-out, please click the button below to confirm. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. Some of these facility improvements include the following: (44), US President Joe Biden met with infant formula manufacturers and retailers, including Reckitt, Gerber, Walmart, and Target, to discuss strategies to get more formula quickly yet safely onto store shelves to solve the ongoing shortage. Find the answers below. There wasnt any connection between their products and the four reported illnesses. (45), The White House released the additional measures they will follow to increase the formula products available without compromising babies safety: (45), The US typically produces nearly all (around 98%) of the infant formulas it needs. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. (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. Why did the FDA not spring into action? 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. But it poses no immediate health risk of food poisoning. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. It will take around three weeks or June 20 before these formulas will hit market shelves. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. But they had to be hospitalized so they could be fed. 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. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Many parents are closely monitoring infant formula and. Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. Moms may have different reasons for choosing a particular formula for their babies. The following are affected by this recall: (2). 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. (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. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. (19). Theyre now investigating the circumstances of the babys death. 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. The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. Only the specific brands, types, and sizes listed above are WIC approved. Jaundice (yellow skin and whites of the eyes). 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. Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. (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. We found no evidence of Salmonella Newport. The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. 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