FDA recall H-0447-2025

GMP Laboratories of America Inc · Class III · food

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 for recall

Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

Distribution

Distribution was to a single customer who received product in California and Oklahoma.

Key facts

Status
Terminated
Initiation date
2025-06-24
Report date
2025-08-20
Termination date
2026-02-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0447-2025