Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, S
Summary
The FDA issued a Class III for Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by by GMP Laboratories of America Inc. Reason: Downstream recall of a dietary supplement ingredient that was manufactured out of specifications..
Details
Source
Food Recall
External ID
H-0447-2025
Action Date
2025-08-20
Status
Terminated
Category
food
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
Lot/Code Info: 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028
Quantity Affected: ~185,482 capsules
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-24
Company
Anaheim, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 113 food recalls issued in the same week, part of 204 food-related FDA actions this month.
GMP Laboratories of America Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GMP Laboratories of America Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GMP Laboratories of America Inc have FDA actions?
GMP Laboratories of America Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0447-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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