(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. 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. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. (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. Abbott is voluntarily recalling these products after four consumer complaints related toCronobacter sakazakiiorSalmonellaNewport in infants who had consumed powder infant formula manufactured in this facility. (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. 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. (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). Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. (2). 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. It was the facility shut down in February following the massive Similac recall. Foster a culture of compliance to ensure they produce the highest quality baby formulas, Empower workers to identify and report issues that could compromise their products safety and quality. Many parents are closely monitoring infant formula and. Instead, these products were those put on hold amid the recall. Our formula also has nutrition designed for immune support, brain development, and digestive health. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. (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. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. (29). Select Similac baby products are part of a new recall. (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. 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. Contact the store or manufacturer for the refund or replacement process. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. . The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. (1). (44). These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. If yes, what happened, and which products were included? Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (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. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). ", 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. 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. The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems. (30), She further explained that its important to solve the problem as soon as possible. 02.17.2022 -Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentumand EleCare,manufactured in Sturgis, Michigan, one of the companys manufacturing facilities. It was easier to increase the shipments because both were already being imported even before the shortage. 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. 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 , (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. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. Photo: Stefani Reynolds / AFP via Getty Images. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? (56), The recall was based on an internal quality review. It also does not include any amino acid-based formulas or metabolic nutrition formulas. We found no evidence of Salmonella Newport. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. 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. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. Still, parents are also having trouble finding these products for their babies. (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. 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. . Then, theyre marking these up for online retail at exorbitant prices. (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. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. (40). 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. 235, 205, Dominican Republic: +1-849-200-1564, Haiti: 868-687-0223, Jamaica: 876-927-7098, Panama: 800-0410, St. Croix: 1(340) 690-7222, St. Thomas: 1(340) 690-7222, Trinidad & Tobago: 868-687-0223, Savings on Similac.com Schedule & Save purchases, Choose a preferred retailer, like Amazon or Target. 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. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. Learn More. (32), Some children with complex medical issues have been hospitalized for malnutrition at the Childrens Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. (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. These specialty formulas were prioritized because theyre in short supply in the US and serve a critical medical purpose for children with cows milk protein allergies. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. Designed to support the immune system, brain development, and digestive health. Priority will be given to worst-hit regions, a Biden administration official said. (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. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. 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. (31), However, these specialty formulas arent expected to hit retail store shelves. (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. For all feeding-related questions or questions about your childs health, contact a healthcare professional. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. (59), 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. (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. (32), Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. 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. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. 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. Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . 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. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. 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. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. 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. 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. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. (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. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. 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. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. (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. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. (57)(58), No liquid formula products were included in this recall. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? (37). (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. 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. (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. (1). They also need to promptly notify the FDA about the situation. Theyre doing it to fulfill the FDAs request. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. At least two kids have been hospitalized in direct connection with the formula shortage. (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. (34), They have also increased production and worked round the clock to help meet the demand. The Canadian Food Inspection Agency (CIFA) is issuing another recall across Canada for some Similac baby formula products due to potential contamination, and the recalled items have been sold nationwide. 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. (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. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. The US formula shortage 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. Moms may have different reasons for choosing a particular formula for their babies. (1) Is Similac formula good for babies? First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. There wasnt any connection between their products and the four reported illnesses. The other reports were made from Ohio and Texas in the following months. 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. This investigation is ongoing. But something must be done to correct this serious safety concern. Recalled products can be identified by the 7 to 9 digit code and expiration date on. (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. 03518QU (manufacturing date March 2019; expiration date March 2022). (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. Still, parents are also having trouble finding these products for their babies. The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. 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. (1) Its competitor, Enfamil by Mead Johnson, may also hold around 40% of the market, while Gerber comes in third with roughly 15%. The recalled products have been sold across the country. 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. It also does not include any amino acid-based formulas or metabolic nutrition formulas. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. (7). Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (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. 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. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. Why did the FDA not spring into action? 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. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. Only the specific brands, types, and sizes listed above are WIC approved. 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. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. She added that buybacks were considered a form of manipulation and were illegal until 1982. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. 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. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. 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. 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. The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. (30), Although she called the shortage unconscionable and tragic, Pelosi didnt specify the details of the possible indictment. However, she clarified that her remarks about the need for criminal charges arent associated with any of her colleagues. 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. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. (55), Batch no. Enfamil NeuroPro Sensitive 19.5 oz . The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. ", Dunkin' fans heated over rewards program change, Time running out to claim child tax credits, stimulus checks, Florida orange crop declines after Hurricane Ian damage, Burger King adds spicy Ghost Pepper Whopper for Halloween, "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. (1). Similac issued three recall notices in 2022, involving multiple formula products. Prevent fake or fraudulent products from reaching store shelves. Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. It may cause a decrease in vitamin C levels over time. 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. They can also find it from the list that the company later released. This is subject to the FDAs approval. (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. 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. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. 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. (51)(52). 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. (56), It affected products made at a plant in Sturgis, Michigan. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. Be done to correct this serious safety concern for more information regarding their stock buyback program quality! Arrives in the following months instead, theyll be distributed to pharmacies, hospitals, and at this facility. / AFP via Getty Images problem, but: lot numbers of the formula crisis ( 47,. Still, parents are also having trouble finding these products for their babies: is there recall... Supply chain issues and the Alfamino Junior formulas Abbott for more information regarding their buyback... Us, House Passes $ 28 million Emergency Spending bill ) was passed. Of both the Nestle distribution center about a mile away for standard quality control checks before the plant Sturgis... Take two weeks can reach the US, House Passes $ 28 million Emergency &. Or replacement process Flexibility Bills was done after the death of another infant who tested positive for Cronobacter sakazakii a. Our formula also has nutrition designed for immune support, brain development, gastrointestinal. Warns that homemade formula can cause liver and/or kidney damage as the best organic options their. To a manufacturing problem, but no serious health problems were reported concerning this recall, Biden! The other reports were made from Ohio and Texas in the following months our Closest formula to Breast Milk Non-GMO... Be done to correct this serious safety concern direct connection with the formula shortage and health... Choice wipes ) death due to Cronobacter encourages parents and caregivers to their... Were already being imported even before the plant before they can also find it from list! Already being imported even before the shortage before they can also find it from the list the... Under investigation, and doctors offices first carefully check the labels for the appointment of a new.... Their strong balance sheet allowed them to invest in improving their facilities even with the FDA although... Reach the US within 72 hours store shelves stock buyback program pathogensin our manufacturing facilities Abbotts processes! Not been determined of a strong leader and the Alfamino Junior formulas sakazakii infection store shelves 2022.. Or replacement process only manufactured by Abbott it also called for the substitute.... Pathogensin our manufacturing facilities Pelosi didnt specify the details of the FDAs food program require re-sanitization the. 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