Food recall

Merical, LLC recall: Walgreens Probiotic 12.5 Billion Active Cultures

Merical, LLC, of Orange, CA, recalled Walgreens Probiotic 12.5 Billion Active Cultures. The FDA's reason: “Incorrect probiotic strain used in formulation which did not match product labeling.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on March 19, 2019, and the FDA first listed it in its Enforcement Report of April 17, 2019. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed January 28, 2020

The recall

Company
Merical, LLC (Orange, CA)
Reason, in FDA's words
“Incorrect probiotic strain used in formulation which did not match product labeling.”
Where it was sold
One customer in IL and then to retail stores nationwide.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
82484

The product recalled

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

  • F-1275-2019 Class III

    Walgreens Probiotic 12.5 Billion Active Cultures, 30 capsules; Dietary Supplement. Probiotic Blend 12.5 Billion CFU's L. rhamnosus HN001, L acidophilus La-14, L reuteri L.RE02. Other ingredients: Cellulose, Gelatin, Silicon Dioxide, Magnesium Stearate (vegetable source)/ Item Number: 981914 Product Number: WGNS 981914 UPC Code: 311917191119 product contains L. acidophilus La-5 strain instead of L. acidophilus La-14 strain as stated on the label. Distributed by Walgreen Co, Deerfield, IL

    Codes: Pkg Numbers: 834627045 and 903727801; Expiration Dates: 06/20

    Quantity: 323 Packaged Cases

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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 April 17, 2019.

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.