. The recall does not include any metabolic deficiency nutrition formulas. 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. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. 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. (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. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market Why did the FDA not spring into action? (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. (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. Abbott Nutrition acknowledges their role in the infant formula shortage. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. (1). 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. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (13). (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. 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. (50). (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. (41)(42). (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. ". Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. (56), The formula has a much lower iron content than the concentration indicated on the label. The USDA (United States Department of Agriculture) is also coordinating with various states to let WIC recipients purchase whatever products are in stock instead of being limited to WIC-approved options. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. For all feeding-related questions or questions about your childs health, contact a healthcare professional. (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. Instead, these products were those put on hold amid the recall. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. (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. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. 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. (43). Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. (29), This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. (28), However, Abbott denies that the buyback program hurt their products safety. Theyre doing it to fulfill the FDAs request. 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. (20). 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. (13). I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. 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. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. They can also find it from the list that the company later released. (55), Batch no. 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. (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. (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. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Our formula also has nutrition designed for immune support, brain development, and digestive health. (42). 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. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. But these include Similac. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. 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 Cronobacter sakazakii. But there were no serious medical complaints reported concerning this Similac recall. It was also quickly approved by the Senate and is now up to Biden to sign into law. 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. (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. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. (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. 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. (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. Prevent fake or fraudulent products from reaching store shelves. Two House bills were passed to address the shortage. 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. You can find more information about these recalls below. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (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. Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. (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. It may cause a decrease in vitamin C levels over time. (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. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. (14)(15), 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. (35), The bill passed in the House with a large bipartisan majority vote. 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. If your product is affected by this recall, dont use it even if it looks alright. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. 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. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. 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. 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. 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