Severity
Low
FDA Food recall · Reported August 20, 2025
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Gmp Laboratories of America Inc recalled Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LL… - a low-severity action.
Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LL… was recalled by Gmp Laboratories of America Inc in August 20, 2025. Reason: Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.. Check the official notice for the remedy. Verify recall #H-0447-2025 with the FDA Food before acting.
The recall
Gmp Laboratories of America Inc issued this low-severity FDA Food recall-Downstream recall of a dietary supplement ingredient that was manufactured out of specifications..
Sourced from official FDA Food enforcement records. Verify recall #H-0447-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Food action (record #H-0447-2025) was formally reported on August 20, 2025, with the manufacturer initiating the action on June 24, 2025. It is classified under Low severity (Class III), with a current status of Terminated. Gmp Laboratories of America Inc is listed as the recalling firm, operating out of Anaheim, CA. Federal records list the affected scope as ~185,482 capsules.
The documented reason for this recall is: Downstream recall of a dietary supplement ingredient that was manufactured out of specifications. Distribution data in the federal record shows the product reached: Distribution was to a single customer who received product in California and Oklahoma.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 609 electronics recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
~185,482 capsules
Related Recalls
6
0 from same agency
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
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | H-0447-2025 |
| Date reported | August 20, 2025 |
| Date initiated | June 24, 2025 |
| Recalling firm | Gmp Laboratories of America Inc |
| Firm location | Anaheim, CA |
| Affected scope | ~185,482 capsules |
| Distribution | Distribution was to a single customer who received product in California and Oklahoma. |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported August 20, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.