Lithium Orotate Products recalled due to Ingredient Manufactured off-spec, United States

United States

GMP Laboratories of America Inc. is recalling certain dietary supplements due to an ingredient manufactured out of specification. The products were distributed to a single customer in California and Oklahoma. The recall was initiated voluntarily by the company on June 24, 2025. approximately 185,482 capsules involved.

AFFECTED PRODUCTS:

PRODUCT: Lithium Orotate 2.5; 60 vegetarian capsules
- Dietary Supplement
- Distributed by Mecene LLC, 447 Sutter St., Suite 405, San Francisco, CA 94108
- Capsules: 2.5 mg and 10 mg
- UPC:
2.5 mg – X002T4OPLL
10 mg – X0031AXVE9
- Lot:
2.5 mg – 21822
10 mg – 21108, 22649
- Expire Date:
2.5 mg – 09/2026
10 mg – 10/2025, 01/2028

PRODUCT: Lithium Orotate, Weyland Brain Nutrition; 60 vegetarian capsules
- Dietary Supplement
- Distributed by Enjoy Nutrition, LLC, San Francisco, CA 94108, (415) 894-0537
- Capsules: 2.5 mg, 5 mg, 10 mg, 20 mg, and 1000 mcg
- UPC:
2.5 mg – X001SBI13J
5 mg – X000PY16Z5
10 mg – X000T9B9B7
20 mg – X001VBLW8H
1000 mcg – X003SBV661
- Lot:
2.5 mg – 21166, 21640, 21821, 22281, 22757
5 mg – 21123, 21300, 21498, 21783, 21994, 22218, 22299, 22457, 22718
10 mg – 21107, 21181, 21288, 21371, 21499, 21695, 21993, 22105, 22200, 22399, 22556, 22650, 22736
20 mg – 21301, 21505, 21911, 22106, 22257, 22397, 22557, 22918
1000 mcg – 21442, 22647
- Expire Date:
2.5 mg – 11/2025, 09/2026, 05/2027, 02/2028
5 mg – 10/2025, 05/2026, 08/2026, 01/2027, 04/2027, 05/2027, 08/2027, 02/2028
10 mg – 10/2025, 12/2025, 02/2026, 03/2026, 05/2026, 07/2026, 01/2027, 01/2027, 03/2027, 07/2027, 10/2027, 01/2028, 02/2029
20 mg – 02/2026, 05/2026, 10/2026, 05/2027, 07/2028, 10/2027, 04/2028
1000 mcg – 05/2025, 01/2027

The issue was discovered through a downstream recall process. The recall is classified as Class III, indicating that the use of the product is not likely to cause adverse health consequences. The classification date was August 8, 2025, and the recall is currently ongoing.

Source: www.accessdata.fda.gov/scripts/ires/index.cfm