CLASS III Food recall · Reported 20 Aug 2025 · FDA Enforcement Report
Lithium Orotate 2.5;, Dietary Supplement recalled
GMP Laboratories of America is recalling Lithium Orotate 2.5;, Dietary Supplement, distributed in California, Oklahoma. The recall was initiated on 24 Jun 2025 and the FDA has classified it as Class III.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- H-0447-2025
- FDA event ID
- 97158
- Recalling firm
- GMP Laboratories of America, Anaheim, CA
- Brand
- Lithium Orotate
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Jun 2025
- FDA classified
- 8 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Product category
- Dietary Supplements
Timeline
| 24 Jun 2025 | Recall initiated by company | |
| 8 Aug 2025 | Classified by FDA | +45 days |
| 20 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distribution was to a single customer who received product in California and Oklahoma.
Questions about this recall
Why was it recalled?
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Which lots are affected?
2.5mg Lot #: 21822 Expire date: 09/2026 10mg Lot#: 21108; 22649 Expire date: 10/2025; 01/2028
Where was it sold?
Distribution was to a single customer who received product in California and Oklahoma.
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97158This product is part of a recall event; the main page for the event is Lithium Orotate, Weyland Brain Nutrition ;, Dietary Supplement recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Lithium Orotate, Weyland Brain Nutrition ;, Dietary Supplement recalledLithium Orotate | GMP Laboratories of America | Potency & Assay | CA, OK |
More recalls from GMP Laboratories of America
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Lithium Orotate, Weyland Brain Nutrition ;, Dietary Supplement recalledLithium Orotate | GMP Laboratories of America | Potency & Assay | CA, OK |
| Food | CLASS II | Dietary supplement recalled by GMP Laboratories of America | GMP Laboratories of America | Packaging Defects | Nationwide |
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| Food | ANNOUNCED | Niwali Tejocote Capsules and Pieces recalled by Global MixNiwali | Global Mix | Foreign Material | Nationwide |
| Food | CLASS I | Addall XR Shot, liquid dietary supplement recalled by ZMB EnterprisesAddall XR | ZMB Enterprises | Hidden Drug Ingredients | CA |
| Food | CLASS II | Super Skin; Dietary Supplement;, 2 per day recalled by Mellish IslandMellish Island | Mellish Island | Other | Nationwide |
| Food | CLASS I | Modern Warrior Ready, Dietary Supplement recalledModern Warrior | Modern Warrior Life | Hidden Drug Ingredients | Nationwide |
| Food | CLASS II | Vista MAX; Dietary Supplement Serving Size recalled by Provision HealthVista MAX | Provision Health | Undeclared Allergens | CA |