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Abbott expands Similac and Pedialyte recall over compromised seals


Abbott Laboratories has expanded an October recall to include millions of bottles of Similac and Pedialyte 2 fluid ounces of ready-to-drink because of compromised seal integrity which could lead to spoilage.

According to the Food and Drug Administration, the recall was initiated on Oct. 13 and is ongoing.

The products included in the recall were produced at the company’s Columbus, OH, manufacturing facility.

These products are being recalled because some bottles in the recalled lots have bottle caps that may not have been sealed completely, which could result in spoilage. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.

The recalled products were distributed in Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia and Wyoming. They were also distributed in Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic and Colombia.

According to the original recall, the products included in the recall were distributed primarily to hospitals and to some doctors’ offices, distributors and retailers.

Recalled products:

# Product Description Recall Number Classification Code Information Product Quantity
1 Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case F-0154-2023 Class II Batch No. 34589N201 Case No. 34589N201 Product No. 59892 Best By 05/01/23 14,588,544 bottles TOTAL
2 Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case F-0155-2023 Class II Batch No. 34589N200 Case No. 34589N200 Product No. 5989213 Best By 04/01/23 14,588,544 bottles TOTAL
3 Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case F-0156-2023 Class II Batch No. 35609N200, 39480N200, 39633N200, 40624N200, 40715N200, 40738N200, 41001N200, 377777N200, 41756N200, 41793N200, 41875N200, 40716N200, 37778N200, 40755N200, 4296N200, 41754N200, 40755N200, 38779N200, 40755N200 Case No. 38493XK00, 39480N200, 39633N200, 40624N200, 40715N200, 41001N200, 41543XK00, 41756N200, 41793N200, 41875N200, 420258H00, 42564XK00, 42566XK00, 42567XK00, 42568XK00, 42572XK00, 42573XK00, 42962N200, 430264R00, 43579XK00, 43580XK00, 43581XK00, 440324R00, 450394R00 Product No. 68133 14,588,544 bottles TOTAL
4 Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit F-0157-2023 Class II Batch No. 39480N200 Case No. 420395E00 Product No. 68264 Best By 04/01/23 14,588,544 bottles TOTAL
5 Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case F-0158-2023 Class II Batch No. 40561N200, 41843N200, 41882N200, 39354N200, 41858N200, 41843N200 Case No. 40561N200, 41843N200, 41882N200, 430294R00, 430304R00, 430314R00, 430328H00, 430338H00, 430348H00, 430358H00, 430368H00, 440408H00 Product No. 68155, 68154, 68152, 68711 Best By 04/01/23, 05/01/23, 06/01/23 15,865,104 TOTAL bottles
6 Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 – 6 count carton F-0159-2023 Class II Batch No. 35609N200 Case No. 380124R00 Product No. 68130 Best By 12/01/22 14,588,544 bottles TOTAL
7 Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case F-0160-2023 Class II Batch No. 35612N200 Case No. 35612N200 Product No. 56177 Best By 12/01/22 14,588,544 bottles TOTAL
8 Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 – 4 packs in a case, 48 count case F-0161-2023 Class II Batch No. 38793N200, 39500N200, 41802N200 Case No. 38793N200, 39500N200, 41802N200 Product No. 67132 Best By 12/01/22, 01/01/23, 03/01/23 14,588,544 bottles TOTAL
9 Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton F-0162-2023 Class II Batch No. 41861N200 Case No. 440344R00 Product No. 67446 Best By 06/01/23 14,588,544 bottles TOTAL
10 Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case F-0163-2023 Class II Batch No. 39799N200 Case No. 39799N200 Product No. 6647634 Best By 04/01/23 14,588,544 bottles TOTAL
11 Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case F-0164-2023 Class II Batch No. 40749N200 Case No. 40749N200 Product No. 6647611 Best By 05/01/23 14,588,544 bottles TOTAL
12 Similac Water – Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case F-0165-2023 Class II Batch No. 39398N200 Case No. 39398N200 Product No. 5100013 Best By 10/01/23 14,588,544 bottles TOTAL

These products should be thrown away or returned to the place of purchase.

Abbott over the past year

Abbott closed its Michigan plant in mid-February after the reports of serious bacterial infections in four infants. The recall and closure worsened an infant formula shortage that began with pandemic supply chain issues. Abbott produces Similac and other popular brands of infant formulas.

According to the CDC and FDA, at least 4 babies were sickened and of those two died, from drinking contaminated Abbott infant formula. The company continues to deny any link to the outbreak, saying its own testing did not find contamination.

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