Lithium Orotate Dietary Supplement Recalled for Out-of-Specification Manufacturing
GMP Laboratories of America Inc is recalling Lithium Orotate dietary supplements (2.5 mg and 10 mg) due to manufacturing out of specifications. The product was distributed to a single customer in California and Oklahoma.
What this means for you
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: FDA Class III designation with no reported illnesses or injuries. Manufacturing defect without documented harm indicates moderate severity, below the 'High' threshold.
Plain-English summary
GMP Laboratories of America Inc is recalling Lithium Orotate dietary supplements in 2.5 mg and 10 mg strengths, distributed in 60-count bottles of vegetarian capsules by Mecene LLC. The products carry UPC codes X002T4OPLL (2.5 mg) and X0031AXVE9 (10 mg).
The recall was initiated because the product was manufactured out of specifications. Approximately 185,482 capsules were affected. Distribution was limited to a single customer with shipments to California and Oklahoma.
The recalled lot numbers are: 2.5 mg Lot #21822 (expiration date 09/2026) and 10 mg Lots #21108 and #22649 (expiration dates 10/2025 and 01/2028, respectively).
The recalled product
- 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
- Manufacturer
- GMP Laboratories of America Inc
- Category
- Drug — Dietary Supplement
- Hazard
- manufacturing-defect
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 (3)
- 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108
- 22649 Expire date: 10/2025
- 01/2028
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27