Dietary Supplement Recalled for Subpotent Folic Acid Content
ActiPharma is recalling ACTIRON Dietary Supplement (Lot 13309, Exp. 01/26) distributed in Puerto Rico because FDA testing found the folic acid content did not meet the label claim.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a minor labeling error where the folic acid specification does not match the label claim. No illnesses or injuries have been reported, and the hazard is documentary rather than immediately health-threatening.
Plain-English summary
ActiPharma, Inc. is recalling ACTIRON Dietary Supplement, 100 tablets, for not meeting the folic acid specification stated on the product label. FDA sample analysis of Lot 13309 (expiration 01/26) determined that the folic acid content in the product fell short of the labeled claim.
Approximately 607 bottles of 100 tablets each were distributed domestically in Puerto Rico. The affected product has UPC 363102217104.
Consumers who have purchased this product should discontinue use and consult with a healthcare provider if they have questions or health concerns. Those seeking additional information may contact ActiPharma, Inc.
The recalled product
- Product
- ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
- Manufacturer
- ActiPharma, Inc.
- Category
- Food — Dietary Supplement
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 13309
- Exp: 01/26
Distribution
Distributed in 1 state:
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