Recall · openFDA Food Enforcement
Lithium Orotate 2.5: FDA Recall H-0447-2025 Agency action: Jun 24, 2025 Record ID: H-0447-2025
View official source ↗ What happened Original notice title
Lithium Orotate 2.5, recall H-0447-2025
From the archived source record
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
What the official notice says to do Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice → Status and source details
Status recorded in the archive Terminated
FDA recall classification Class III
Recall initiated by Voluntary: Firm initiated
Report date Aug 20, 2025
Termination date in the archive Feb 24, 2026
Source checked Jul 16, 2026
Record revision 266f6b4799dc This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage → What is affected 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 Company GMP Laboratories of America Inc Lot / identifier 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028 Market / distribution Distribution was to a single customer who received product in California and Oklahoma. Quantity reported ~185,482 capsules What is affected 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 Company GMP Laboratories of America Inc Lot / identifier 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028 Market / distribution Distribution was to a single customer who received product in California and Oklahoma. 