(21), According to the FDAs food director, Susan Mayne, they were unable to fully determine if theres a match because they only had sequences from two babies. Between the lines: Abbott said the 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. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. (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. 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. (36), A total of 192 Republican lawmakers voted against the bill, claiming that throwing millions of dollars at the problem wont fix it. (36), The Houses budget measure is expected to meet more resistance in the Senate. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. 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. 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. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. ". (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. Before sharing sensitive information, make sure you're on a federal government site. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. Similac Pro-Advance Non-GMO Infant Formula with Iron, Earths Best Non-GMO Soy-Based Infant Powder Formula, Else Plant-Based Complete Nutrition for Toddlers, Baby Wipes Recall 2022: Affected Brands & Toxic Products, Similac Pro-Sensitive Vs. Similac Sensitive, Similac Pro-Sensitive Vs. 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Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. Follow the directions in the email to reset your password. However, she warned that formula dilution can lead to organ failure or brain swelling. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. * Offers may vary. (39). Some brands have very similar packaging for different types of formula. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. 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. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. (1). (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. (56), The Similac recall involved dozens of different lots and products. The following are some of the baby formulas recalled in 2021: These are imported products from Europe distributed by the online retail store LittleBundle website starting May 20, 2021. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. Contains no artificial growth hormones and is non-GMO. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. 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. (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. 02.17.2022 - Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company's manufacturing facilities. (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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. (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. during the first recall, then Similac PM 60/40 in the second recall. 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. She added that buybacks were considered a form of manipulation and were illegal until 1982. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. The site is secure. 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. (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. (31). Affected customers were advised to search for the lot number of their item at similac.com/recall. Symptoms may include irritability with generalized tenderness. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. (1) Its competitor, Enfamil by Mead Johnson, may also hold around 40% of the market, while Gerber comes in third with roughly 15%. ", 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. (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. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. They havent confirmed how many formula units have been recalled. 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. 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. Prevent fake or fraudulent products from reaching store shelves. The baby had consumed Similac PM 60/40 from this lot. 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). Still, parents are also having trouble finding these products for their babies. The products included in the recall were distributed primarily to hospitals and to some doctors offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. 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. 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. 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. (31), However, these specialty formulas arent expected to hit retail store shelves. It was easier to increase the shipments because both were already being imported even before the shortage. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. Designed to support the immune system, brain development, and digestive health. (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. It may also cause bowel damage and can spread through the blood to other parts of the body. 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. The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. (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. Update password per the new system standards (8 Characters). More are expected to arrive on three more flights in the coming weeks. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). (18), Similac Pro-Total Comfort (Powder) infant formula, Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, Abbott Reopens Formula Plant, Starts EleCare Production, Some Global Companies To Send Formulas As US Shortage Hits 70%, 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. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. (36). 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. Recalls. (1) Is Similac formula good for babies? For all feeding-related questions or questions about your childs health, contact a healthcare professional. If a product is included in the recall, do not use the product. Why did it take four months to pull this formula off store shelves? During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. Learn More. It was also quickly approved by the Senate and is now up to Biden to sign into law. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). Recalled products can be identified by the 7 to 9 digit code and expiration date on. Select Similac baby products are part of a new recall. 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. If you still wish to opt-out, please click the button below to confirm. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. Enfamil NeuroPro Sensitive 19.5 oz . Otherwise, click Cancel to return to your profile. 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 (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). 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. . Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. 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. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. One of the cases was fatal. (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. 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. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. 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. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. Theyre now investigating the circumstances of the babys death. (56), It affected products made at a plant in Sturgis, Michigan. Many formulas from name brands like Similac are designed to closely resemble breast milk. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. 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. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? Federal inspectors found several safety violations: (43)(51)(52). According to the hospital spokesperson, the kids ranged from babies to older children. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. Photo: Stefani Reynolds / AFP via Getty Images. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. (50). (24)(25), These are some of the steps they need to comply with: (24)(25), The company must also review and change the following: (24), If any contamination is detected, Abbott is required to immediately stop production. (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. (2). (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. But there were no serious medical complaints reported concerning this Similac recall. (3), Symptoms of sepsis and meningitis can include: (2). 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It will take around three weeks or June 20 before these formulas will hit market shelves. We found no evidence ofSalmonellaNewport. . 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. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. 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. 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