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GMP Laboratories of America Inc
FDA recall H-0447-2025 · Class III · reported 2025-08-20 · Terminated
- Product
- 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
- Reason
- Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
- Quantity
- ~185,482 capsules
- Distribution
- Distribution was to a single customer who received product in California and Oklahoma.
- Firm location
- CA, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Telephone
- Recall started
- 2025-06-24
- Terminated
- 2026-02-24
- Code info
- 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.