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Class III: unlikely to cause harmTerminated

GMP Laboratories of America Lithium Orotate 2 Recall

Lithium Orotate 2

GMP Laboratories of America Inc · Anaheim, CA

Risk level
Class III
Reported by FDA
Aug 20, 2025
Recall ID
H-0447-2025
Check your lot numberHow we source this data

Summary

GMP Laboratories of America recalled Lithium Orotate 2 starting Jun 24, 2025. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report H-0447-2025 on Aug 20, 2025. Reason: Downstream recall of a dietary supplement ingredient that was manufactured out of specifications. Status: Terminated.

Why it was recalled

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

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 numbers, UPCs & expiration codes

2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
H-0447-2025
Classification
Class III
Status
Terminated
Recall initiated
Jun 24, 2025
FDA report date
Aug 20, 2025
Quantity
~185,482 capsules
Recall type
Voluntary: Firm initiated
Recalling firm
GMP Laboratories of America Inc

Original FDA data

Every field from FDA enforcement report H-0447-2025, exactly as published.

Show all FDA fields
City
Anaheim
State
CA
Status
Terminated
Country
United States
Event ID
97158
Address
2931 E La Jolla St
Code information
2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028
Postal code
92806-1306
Report date
Aug 20, 2025
Product type
Food
Recall number
H-0447-2025
Classification
Class III
Recalling firm
GMP Laboratories of America Inc
Product quantity
~185,482 capsules
Termination date
Feb 24, 2026
Reason for recall
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Distribution was to a single customer who received product in California and Oklahoma.
Recall initiation date
Jun 24, 2025
Initial firm notification
Telephone
Center classification date
Aug 8, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report H-0447-2025, published Aug 20, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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