The baby reportedly consumed formula made by Abbott Nutrition. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. 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. The following are affected by this recall: (2). (20). Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. (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. (44). (31), Aside from ramping up productions, Biden also launched Operation Fly Formula. He directed various government agencies to use the Department of Defense planes to pick up formulas that meet U.S. standards overseas and fly these to the U.S. to help restock shelves. (4), Although the February 2022 Similac recall due to bacterial infections (discussed in detail below) is among the main causes of the formula shortage, authorities explained that supply chain issues and higher demands were already causing a shortage even in 2021. 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. 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. (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. (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. (1). 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. Abbott Nutrition said it is cooperating with the FDA investigation into the three Cronobacter sakazakii infections and one salmonella infection, all of which required hospitalization. Update password per the new system standards (8 Characters). (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. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. (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. (2). (32). 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. More are expected to arrive on three more flights in the coming weeks. Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. (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. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. Select Similac baby products are part of a new recall. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. (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. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. 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. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. 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 they had to be hospitalized so they could be fed. FDA does not endorse either the product or the company. Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. (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. (7), It might have played a big role in the shortage and can be held liable, depending on the outcome of the Justice Departments investigation. (7). The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. Withdrawals, & The baby had consumed Similac PM 60/40 from this lot. (31). (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. 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. Find the answers below. How many infants were fed contaminated formula during this time? (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. 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. 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. Lax practices in terms of clean in place procedures, Failed to take corrective measures after knowing their testing procedures were deficient, Had an atmosphere of retaliation against employees who raised concerns about their company practices. Contact the store or manufacturer for the refund or replacement process. 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 . 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. The site is secure. 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. 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. We want to extend our heartfelt sympathies to the family. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. (49). (3), Symptoms of sepsis and meningitis can include: (2). If your product is affected by this recall, dont use it even if it looks alright. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). 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. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. 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. , which shouldnt have been sold back to consumers at all. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. You can find more information about these recalls below. 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. (43). Photo: Stefani Reynolds / AFP via Getty Images. The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. (34), The FDA is also planning to update its review process for more foreign manufacturers to ship more formula products to the US and boost imports. 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. The recall does not include any metabolic deficiency nutrition formulas. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). 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. (57)(58), No liquid formula products were included in this recall. bacteria, which caused serious infections. (21), Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee, explained that this will increase the FDAs staff so more of them can do the following: (21), However, this bill has been met with resistance, with other lawmakers such as Rep. Bill Huizenga saying that more formula production is needed, not more FDA staff. (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. 2 fl oz ready-to-feed liquid products included in this voluntary recall: Its important to note that not all recalled products were distributed in all countries and not all 2 fl oz/59 ml formulas are included in the recall. Agriculture Secretary Tom Vilsack explained that this first batch can provide enough formula for around 9,000 babies and 18,000 toddlers for one week. (35), The bill passed in the House with a large bipartisan majority vote. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (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. 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. But something must be done to correct this serious safety concern. (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. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. Still, parents are also having trouble finding these products for their babies. This is subject to the FDAs approval. (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. They havent confirmed how many formula units have been recalled. Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. This voluntary recall only affected products sold in the Philippines. If you still wish to opt-out, please click the button below to confirm. (31), However, these specialty formulas arent expected to hit retail store shelves. The recall does not include any metabolic deficiency nutrition formulas. It was the facility shut down in February following the massive Similac recall. The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. 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 , 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. 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. 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. Many parents are closely monitoring infant formula and. The recall includes these 2 fl. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. Directions apply to Chrome onAndroid devices. Similac 360 Total Care Affected bottle and carton or case lot numbers in the US: (1) 35609N200; 38493XK00 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti) 40716N200; 42567XK00 40755N200; 43579XK00 Affected lots with the same bottle and case numbers: (1) 39633N200 40624N200 Theyre doing it to fulfill the FDAs request. (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. One of the cases was fatal. Thankfully, the children have all been discharged. Some might feel more secure choosing a well-known brand name. 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. 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. (37). (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). There wasnt any connection between their products and the four reported illnesses. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. Moms may have different reasons for choosing a particular formula for their babies. The FDA had actually conducted plant inspections in September. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. Federal inspectors found several safety violations: (43)(51)(52). 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. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. (55), Batch no. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (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. (28), However, Abbott denies that the buyback program hurt their products safety. 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. (29). Designed to support the immune system, brain development, and digestive health. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. (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. The recalled products have been sold across the country. 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. during the first recall, then Similac PM 60/40 in the second recall. . (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. 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. But it poses no immediate health risk of food poisoning. 8 oz (6 p ack) ready to feed . Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. It is therefore important to verify the product lot number on the bottom or the side of the bottle. Why did the FDA not spring into action? You can check if your powdered formula is affected by inspecting the code printed near the expiration date. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Then, theyre marking these up for online retail at exorbitant prices. (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. (4). Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. 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. Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. (9), The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. I am equally concerned that the FDA reacted far too slowly to this report. 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. It will take around three weeks or June 20 before these formulas will hit market shelves. 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