Class IIITerminated in FDA datasetRecall initiated Jun 24, 2025

Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement

Recalling firm: GMP Laboratories of America Inc

Why it was recalled

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

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Feb 24, 2026.

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ProductLithium 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

FDA code information

2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028

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Full FDA record and distribution details

Original 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

Original FDA recall reason

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

Recall details

Recall number
H-0447-2025
Event ID
97158
FDA status
Terminated
Initiated
Jun 24, 2025
Reported
Aug 20, 2025
Classified
Aug 8, 2025
Terminated
Feb 24, 2026
Quantity
~185,482 capsules
Location
Anaheim, CA, United States
Initiation type
Voluntary: Firm initiated
Notification
Telephone

Where it was distributed

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

FDA source record · H-0447-2025

Data updated September 16, 2026. View official FDA data ↗

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