FDA Recall United States Terminated Historical recordClass III
GMP Laboratories of America Inc
- Product
- Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian cap…
- Published
- August 20, 2025
- Distribution
- Distribution was to a single customer wh…
GMP Laboratories of America Inc Recall: Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
United States
TerminatedClass III
- Company
- GMP Laboratories of America Inc
- Product
- Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplem…
- Recall date
- June 24, 2025
- Terminated
- February 24, 2026
- Source
- FDA
Reason for recall
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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 | Not published in this source record | ~185,482 capsules | 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028 |
Distribution
- Distribution was to a single customer who received product in California and Oklahoma.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- H-0447-2025
- Event ID
- 97158
- Status
- Terminated
- Classification
- Class III
- Company
- GMP Laboratories of America Inc
- 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
- Quantity
- ~185,482 capsules
- Reason
- Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
- Recall initiation date
- June 24, 2025
- Report date
- August 20, 2025
- Classification date
- Not published in this source record
- Termination date
- February 24, 2026
- Distribution pattern
- Distribution was to a single customer who received product in California and Oklahoma.
- UPC, lot, and code information
- 2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Telephone
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Other products recalled under this same event
This recall shares FDA event ID 97158 with 1 other product entry in Public Health Trace.
Responsible company: GMP Laboratories of America Inc
Other recalls from GMP Laboratories of America Inc
FDA Recall United States Terminated Historical recordClass III
GMP Laboratories of America Inc
- Product
- Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian cap…
- Published
- August 20, 2025
- Distribution
- Distribution was to a single customer wh…
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
