H-0447-2025
GMP Laboratories of America Inc
Data retrieved 2026-10-27T22:06:49.008Z
Site-assigned category (for this product recall): Other
Independent website; not affiliated with or endorsed by FDA. Recall information is attributed to the linked FDA record. Categories are assigned by this website using keyword rules; they are not FDA classifications or independent legal findings and may be incomplete or incorrect. A category summarizes the stated reason for the identified product recall, not a finding about the firm generally or its other products. FDA’s original reason text appears below.
Official openFDA record · FDA recalls and safety alerts
Fields as reported by FDA
Dates are formatted YYYY-MM-DD. “Not reported” means the field was absent or empty.
- recall_number
- H-0447-2025
- event_id
- 97158
- recalling_firm
- GMP Laboratories of America Inc
- city
- Anaheim
- state
- CA
- country
- United States
- 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
- reason_for_recall
- Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
- classification
- Class III
- FDA-reported status (not current status)
- Terminated
FDA does not update this status after recall classification. It may not reflect whether the recall is currently ongoing, completed, or terminated. - voluntary_mandated
- Voluntary: Firm initiated
- distribution_pattern
- Distribution was to a single customer who received product in California and Oklahoma.
- product_quantity
- ~185,482 capsules
- code_info
- 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028
- recall_initiation_date
- 2025-06-24
- report_date
- 2025-08-20
- termination_date
- 2026-02-24