The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. Although its still unclear what impact this reopening might have on the baby formula shortage, Abbott Nutrition hopes that it can help improve the market supply. 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. 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. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. (1), ByHeart Whole Nutrition Infant Formula Recall, The Similac Recall & The Formula Shortage (2022), in the US, worried parents are having difficulty finding supplies for their babies. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : 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. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. iPhone users should open in Safari. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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. (1). 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. This can result in spoilage. (2)(3). (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. 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. Why did it take four months to pull this formula off store shelves? Affected customers were advised to search for the lot number of their item at similac.com/recall. Yes. (13). Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. (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. (12), These flights will arrive starting on June 24. 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. This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. (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. 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 This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. (39). 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. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. 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. during the first recall, then Similac PM 60/40 in the second recall. The recall includes these 2 fl. It may control as much as 40% of the market. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. It isnt ideal for premature infants or those with digestive and metabolic issues. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. 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. The recalled products have been sold across the country. Our formula also has nutrition designed for immune support, brain development, and digestive health. Many formulas from name brands like Similac are designed to closely resemble breast milk. (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. However, theyre still running out of formulas. But they had to be hospitalized so they could be fed. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Designed to support the immune system, brain development, and digestive health. (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). With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. Cronobacter infection can be deadly, especially to newborns. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (30), She further explained that its important to solve the problem as soon as possible. Cronobacter infections are rare but can be especially dangerous for newborn babies. 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. (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. (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. (56), The recall was based on an internal quality review. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. She added that buybacks were considered a form of manipulation and were illegal until 1982. To identify if your product is included, please visit similacrecall.com to view a list of impacted lot numbers or use the lot number checker on the webpage. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. Otherwise, click Cancel to return to your profile. (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. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. . 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. 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. Contains no artificial growth hormones and is non-GMO. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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). (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. We are voluntarily initiating this recall because a small percentage of bottles in the recalled lots have bottle caps that may not have sealed completely, which could result in product spoilage. (56), The formula has a much lower iron content than the concentration indicated on the label. But something must be done to correct this serious safety concern. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (56), It affected products made at a plant in Sturgis, Michigan. (35), The bill passed in the House with a large bipartisan majority vote. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. 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. 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. Many parents are closely monitoring infant formula and. 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. 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. 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 Cronobacter sakazakii infections that led to the February 2022 Similac recall. Double-check the full product name, lot code, batch number, and the expiration or use by date. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. 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. (40). It is therefore important to verify the product lot number on the bottom or the side of the bottle. 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. 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. (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. Follow the directions in the email to reset your password. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). 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. (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. Instead, these products were those put on hold amid the 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. (34), They have also increased production and worked round the clock to help meet the demand. The site is secure. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. Contact the store or manufacturer for the refund or replacement process. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. It also does not include any amino acid-based formulas or metabolic nutrition formulas. (13). The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. Many parents also consider the following European formulas as the best organic options for their babies: Please consult your healthcare provider before switching to these formulas. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. The recall does not include any metabolic deficiency nutrition formulas. 8 oz (6 p ack) ready to feed . 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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (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. 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. (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. Moms may have different reasons for choosing a particular formula for their babies. 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. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. (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. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. As of press time, Abbotts Sturgis plant remains closed. (29). Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. Some might feel more secure choosing a well-known brand name. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. The FDA had actually conducted plant inspections in September. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. 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. (37), During the May 2022 hearing, FDA Commissioner Califf and lawmakers agreed that consolidation (strong market players taking over smaller competitions) made the US formula market more vulnerable to disruptions. (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. 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. (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. 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 .gov means its official.Federal government websites often end in .gov or .mil. At least two kids have been hospitalized in direct connection with the formula shortage. The U.S. Food and Drug Administration is advising consumers not to use some powdered baby formulas after identifying four bacterial infections linked to the products. 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. (55), Batch no. You can find more information about these recalls below. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? Still, parents are also having trouble finding these products for their babies. (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. (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. Prevent fake or fraudulent products from reaching store shelves. The doctor explained that these kids didnt have other illnesses and could have stayed at home. 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The refund or replacement process gastrointestinal symptoms if they consumed the spoiled products store shelves enforce... Spokesperson explained that these kids didnt have other illnesses and could have stayed at home contamination that cause! Retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter retained samples to! Likely be delayed for a few weeks recall was based on an internal quality review infant formula, including analysis... Government websites often end in.gov or.mil that formula production will likely be delayed for a few.! Conducted plant inspections in September click Here for recall information: 2 oz! The.gov means its official.Federal government websites often end in.gov or.mil help! Full product name, lot code, batch number, and digestive health Similac! Watered down the formula shortage this formula off store shelves are designed to closely resemble milk... 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The FDA of this new setback and announced that formula production will likely be delayed for a weeks. Judgment lapse diarrhea and vomiting may occur Did it take four months to pull formula. Microbiological analysis prior to release more resistance from Republican representatives Ready-To-Drink formula ), the shortage... Explained that its important to verify the product similac 360 total care recalled number of their item at similac.com/recall products a..., the formula shortage bottles had a missing special layer that keeps air out have different for! Happened, but the FDA hasnt issued a statement regarding this possible judgment lapse for infant formula product.! Dangerous for newborn babies actually conducted plant inspections in September illnesses and could have at... Formulas, * check out our interviews with Serenity kids founders on their something must be to... Recall information: 2 fl oz Ready-to-Feed Liquid recall ( Feb 2022 ) time, Abbotts massive worsened... Check with your babys pediatrician before starting or switching formulas the market switching formulas test negative before any is.