RecallHawk
Class III Recall

Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, L

GMP Laboratories of America Inc

Summary

The FDA issued a Class III for Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Suppl by GMP Laboratories of America Inc. Reason: Downstream recall of a dietary supplement ingredient that was manufactured out of specification..

Details

Source

Food Recall

External ID

H-0448-2025

Action Date

2025-08-20

Status

Terminated

Category

food

Product Description

Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, LLC. San Francisco, CA 94108, (415) 894-0537 2.5 mg UPC#: X001SBI13J 5 mg UPC#: X000PY16Z5 10 mg UPC#: X000T9B9B7 20 mg UPC#: X001VBLW8H 1000 MCG UPC#: X003SBV661

Lot/Code Info: 2.5mg Lot #: 21166, 21640, 21821, 22281, 22757 Expire date: 11/2025, 09/2026, 05/2027, 02/2028 5 mg Lot#: 21123, 21300, 21498, 21783, 21994, 22218, 22299, 22457, 22718 Expire date: 10/2025, 05/2026, 08/2026, 01/2027, 04/2027, 05/2027, 08/2027, 02/2028 10mg Lot#: 21107, 21181, 21288, 21371, 21499, 21695, 21993, 22105, 22200, 22399, 22556, 22650, 22736 Expire date: 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 20mg Lot#: 21301, 21505, 21911, 22106, 22257, 22397, 22557, 22918 Expire date: 02/2026, 05/2026, 10/2026, 05/2027, 07/2028, 10/2027, 04/2028 1000 MCG Lot#: 21442, 22647 Expire date: 05/2025, 01/2027

Quantity Affected: ~185,482 capsules

Reason for Recall

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

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2025-06-24

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-0448-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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