Food recall

ActiPharma, Inc. recall: ACTIRON Dietary Supplement, ActiPharma

ActiPharma, Inc., of Guaynabo, PR, recalled ACTIRON Dietary Supplement, ActiPharma. The FDA's reason: “FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on September 28, 2023, and the FDA first listed it in its Enforcement Report of November 29, 2023. 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 16, 2024

The recall

Company
ActiPharma, Inc. (Guaynabo, PR)
Reason, in FDA's words
“FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.”
Where it was sold
Domestic distribution, in Puerto Rico.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
93210

The product recalled

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

  • F-0463-2024 Class III

    ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.

    Codes: Lot 13309, Exp: 01/26

    Quantity: 607 bottles of 100 tablets each

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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 29, 2023.

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.