Food recall

Abbott Laboratories recall: Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case

Abbott Laboratories, of Columbus, OH, recalled Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case and 11 other products. The FDA's reason: “Compromised seal integrity which could lead to spoilage.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on October 13, 2022, and the FDA first listed it in its Enforcement Report of November 23, 2022. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Other germs or toxins (botulism, hepatitis A, mold...)

Status

Terminated

Closed August 14, 2024

The recall

Company
Abbott Laboratories (Columbus, OH)
Reason, in FDA's words
“Compromised seal integrity which could lead to spoilage”
Where it was sold
Domestic: 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, Wyoming Foreign: Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
91003

The 12 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0154-2023 Class II

    Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case

    Codes: Batch No. 34589N201 Case No. 34589N201 Product No. 59892 Best By 05/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0155-2023 Class II

    Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case

    Codes: Batch No. 34589N200 Case No. 34589N200 Product No. 5989213 Best By 04/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0156-2023 Class II

    Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case

    Codes: 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, 68136, 68708, 68133 Best By 12/01/22, 02/01/23, 03/01/23, 04/01/23, 05/01/23, 06/01/23, 07/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0157-2023 Class II

    Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit

    Codes: Batch No. 39480N200 Case No. 420395E00 Product No. 68264 Best By 04/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0158-2023 Class II

    Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case

    Codes: 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

    Quantity: 15,865,104 TOTAL bottles

  • F-0159-2023 Class II

    Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton

    Codes: Batch No. 35609N200 Case No. 380124R00 Product No. 68130 Best By 12/01/22

    Quantity: 14,588,544 bottles TOTAL

  • F-0160-2023 Class II

    Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case

    Codes: Batch No. 35612N200 Case No. 35612N200 Product No. 56177 Best By 12/01/22

    Quantity: 14,588,544 bottles TOTAL

  • F-0161-2023 Class II

    Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case

    Codes: Batch No. 38793N200, 39500N200, 41802N200 Case No. 38793N200, 39500N200, 41802N200 Product No. 67132 Best By 12/01/22, 01/01/23, 03/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0162-2023 Class II

    Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton

    Codes: Batch No. 41861N200 Case No. 440344R00 Product No. 67446 Best By 06/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0163-2023 Class II

    Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

    Codes: Batch No. 39799N200 Case No. 39799N200 Product No. 6647634 Best By 04/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0164-2023 Class II

    Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

    Codes: Batch No. 40749N200 Case No. 40749N200 Product No. 6647611 Best By 05/01/23

    Quantity: 14,588,544 bottles TOTAL

  • F-0165-2023 Class II

    Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

    Codes: Batch No. 39398N200 Case No. 39398N200 Product No. 5100013 Best By 10/01/23

    Quantity: 14,588,544 bottles TOTAL

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of November 23, 2022.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.