FDA recall record

GMP Laboratories of Lithium Orotate 2.5 recall — FDA H-0447-2025

Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

Class IIIclassification
H-0447-2025official record ID
Aug 20, 2025report date

Recall record at a glance

Official recordH-0447-2025
CategoryFood Recalls
ClassificationClass III
FDA record statusTerminated
Recalling firmGMP Laboratories of America Inc
Report dateAug 20, 2025
Recall initiation dateJun 24, 2025
Quantity~185,482 capsules
LocationAnaheim, CA, United States

Official product description

Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, San Fransisco, CA 94108 2.5 mg UPC#: X002T4OPLL 10 mg UPC#: X0031AXVE9

Why the product was recalled

Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

Distribution information

Distribution was to a single customer who received product in California and Oklahoma.

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Telephone.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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