Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Still, parents are also having trouble finding these products for their babies. Two House bills were passed to address the shortage. Bing Guan/Reuters The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. 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. Top FDA Official Resigns Over Formula Shortage, Abbott Under Criminal Investigation Over Possible Role In Baby Formula Shortage, Enfamil Maker Believes Shortage Will Last Until Spring, FDA Plans To Allow Overseas Formulas Beyond Shortage, FDA Investigates Another Abbott Formula-related Baby Death, Newly Reopened Abbott Plant Shuts Again Due To Floods, After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the, 95,000 cans arrived in LAX for Walmart, Albertsons Companies, and The Kroger Company grocery stores from Australia. The .gov means its official.Federal government websites often end in .gov or .mil. Directions apply to Chrome onAndroid devices. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. (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. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. . (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. ". It may control as much as 40% of the market. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. But they had to be hospitalized so they could be fed. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. If a product is included in the recall,do not use the product. It can even lead to an imbalance in your babys body that might cause their heart to stop. (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). Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. powder . 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. Call Similac for refund processing or product replacement. * Offers may vary. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport, Abbott also reminds parents and caregivers that, can be commonly found in the environment and a variety of areas around the home. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. 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. The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. (56), It affected products made at a plant in Sturgis, Michigan. 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. The FDA said environmental samples from the facility have yielded positive results for the Cronobacter bacteria, but there have been no reports of salmonella so far. 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 . (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. (37). They havent confirmed how many formula units have been recalled. 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. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. 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. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. 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.". 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 was also quickly approved by the Senate and is now up to Biden to sign into law. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Find the answers below. FDA Details Safety Issues At Abbott Plant Linked To Formula Recalls, Failure to maintain the sanitary conditions of surfaces used to prepare and handle formula, bacteria contamination between fall 2019 and February 2022. 02.28.2022 UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot #27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. They can also find it from the list that the company later released. 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. 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. 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. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. The baby had consumed Similac PM 60/40 from this lot. (49). Those infected with salmonella might experience fever, diarrhea and abdominal cramps. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. Still, parents are also having trouble finding these products for their babies. , which shouldnt have been sold back to consumers at all. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. Priority will be given to worst-hit regions, a Biden administration official said. (13). Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. If yes, what happened, and which products were included? FDA does not endorse either the product or the company. (2). 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. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. Our formula also has nutrition designed for immune support, brain development, and digestive health. (26), Since Abbott has over 40% share of the US infant formula market, their formula recall and subsequent plant shutdown badly affected the formula supply. However, theyre still running out of formulas. (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. (29). Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Update password per the new system standards (8 Characters). I am equally concerned that the FDA reacted far too slowly to this report. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. 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. It isnt ideal for premature infants or those with digestive and metabolic issues. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: Join Similac Rewards for up to $400*in benefits and support throughout your journey. hide caption. (60), According to the FDA, premature babies fed with this formula for over a month may have a higher risk of developing iron-deficiency anemia because of insufficient iron intake. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. 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 Comfort TM, Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure , 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. Abbott Nutrition issued a voluntary recall of certain lots of ready-to-feed liquid products (2 fl oz or 59 ml bottles), produced at their manufacturing facility in Columbus, Ohio, due to a manufacturing defect. 03518QU (manufacturing date March 2019; expiration date March 2022). (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. 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. 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. First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. 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. It may also cause bowel damage and can spread through the blood to other parts of the body. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. Moms may have different reasons for choosing a particular formula for their babies. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. Then, theyre marking these up for online retail at exorbitant prices. (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. The FDA clarifies that the recall is still in effect even though the investigation is closed. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. (56), The Similac recall involved dozens of different lots and products. (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. If a product is included in the recall, do not use the product. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. oz/59 ml ready-to-feed products: U.S. - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort . Many formulas from name brands like Similac are designed to closely resemble breast milk. Similac 360 Total Care Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed to support the immune system, brain development and digestive health. (28), However, Abbott denies that the buyback program hurt their products safety. Before sharing sensitive information, make sure you're on a federal government site. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. (36). (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. Republicans are questioning why the FDA isnt held accountable for the shortage and the possible lapses that led to the deaths of the two babies linked to the Abbott products. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. (40). 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. 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