", 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. Key ingredients found in breast milk including 5 HMO prebiotics. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. (56), The recall was based on an internal quality review. (56), It affected products made at a plant in Sturgis, Michigan. Password reset email has been sent. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. 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. Safeguarding Infant Health during the Recall 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. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. 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. (46), Retailers like Target, CVS, and Walmart have since put a cap on the number of formula packs that consumers can buy online and from their stores. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. * Offers may vary. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Why did the FDA not spring into action? Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. Priority will be given to worst-hit regions, a Biden administration official said. 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. The recalled products have been sold across the country. It also does not include any amino acid-based formulas or metabolic nutrition formulas. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : However, theyre still running out of formulas. 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. (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. 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. Similac issued three recall notices in 2022, involving multiple formula products. It isnt ideal for premature infants or those with digestive and metabolic issues. 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. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. 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. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. 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. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. (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. 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. 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. Similac 360 Total Care Sensitive 30.2 oz. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. (21), The first two Defense Production Act authorizations are priority orders for Reckitt Benckiser (Mead-Johnsons Enfamil) and Abbott Nutrition: (31), Once the Abbott plant resumes operations, these priority shipments are expected to help increase their production by one-third. There werent any new cases identified as part of the investigation. (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. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. What they're saying: "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," the company said in a statement. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. (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. This is subject to the FDAs approval. Photo: Stefani Reynolds / AFP via Getty Images. The following are affected by this recall: (2). Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. (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. 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. 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. (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. 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. 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. Call your pediatrician or doctor if your child shows signs of medical issues (such as stomach upset) from drinking the recalled product. The baby had consumed Similac PM 60/40 from this lot. 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. 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. Instead, these products were those put on hold amid the recall. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. Designed to support the immune system, brain development, and digestive health. Before sharing sensitive information, make sure you're on a federal government site. 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), 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. (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. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. It will take around three weeks or June 20 before these formulas will hit market shelves. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. 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. (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. (7). (50). At least two kids have been hospitalized in direct connection with the formula shortage. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. 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. We found no evidence ofSalmonellaNewport. 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 , (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. (29), Califf insisted that theres a need for major improvements at the FDA, not because people were bad but because they needed the right resources and consistent leadership. (26), Abbotts head detailed the serious steps the company is taking to address the baby formula shortage: (26), Once the production resumes at Sturgis, Michigan, Ford detailed that they will do the following: (26), While Abbott maintains that the strains from the FDAs investigations dont match those taken from their facility, FDA officials recently refuted this claim. 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. According to the recall advisory, products from Abbott Nutritions Sturgis, Michigan facility have been distributed across the US and likely to have been exported to other countries. (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. (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. 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 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. 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. (6), He explained that he inherited the decentralized structure of the foods program, which kept his office from functioning as an integrated team and subsequently protecting the public. (12), These flights will arrive starting on June 24. 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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. Recalled products can be identified by the 7 to 9 digit code and expiration date on. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. "We'll do whatever it takes to keep that trust and resolve this situation. 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. CNN Abbott Labs said Friday that it is recalling certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid formula for infants and children due to a problem with the bottle caps. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. 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. . 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 . (57)(58), No liquid formula products were included in this recall. If you still wish to opt-out, please click the button below to confirm. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. If you have any of these products, dont feed them to your baby. 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. 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. By opting-out, you are removing your phone number from your Similac profile. (11), According to the FDA, the infant death reportedly happened in January. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market It was also quickly approved by the Senate and is now up to Biden to sign into law. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. (4), Thats why theres also a shortage in the store brands like. (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. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. ". However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. Thankfully, the children have all been discharged. Reckitt facilities can also operate at their maximum capacity following these shipments. 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. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. 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. (49). Why did the FDA not spring into action? 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. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. (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. Bing Guan/Reuters Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. (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. (36). If your infant is experiencing symptomsrelated toCronobacterorSalmonellainfection,such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care. , involving multiple formula products were those put on hold amid the recall or down... Completed batch of infant formula shortage that trust and resolve this situation these flights will starting... More '' button to see lot numbers included in the market and alleviate the formula shortage problem.., Mich., facility, we found evidence of Cronobacter results from environmental samples by. Facilities can also operate at their maximum capacity following these shipments wish to opt-out, please click the button to. Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17, the have! 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