The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Food)·H-0447-2025·Announced 2025-08-20

Mecene lithium orotate capsules recalled after an out of specification ingredient

Lithium Orotate capsules distributed by Mecene LLC are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall arising from an out-of-specification ingredient upstream, with no health consequence stated in the source.

Plain-English summary

Lithium Orotate, 60 vegetarian capsules per bottle, a dietary supplement distributed by Mecene LLC of San Francisco, is being recalled across the 2.5 mg and 10 mg strengths. The action covers approximately 185,482 capsules.

The stated reason is a downstream recall of a dietary supplement ingredient that was manufactured out of specifications. The FDA classified the action as Class III, its least serious classification.

The affected 2.5 mg lot is 21822, expiring 09/2026, and the affected 10 mg lots are 21108 and 22649, expiring 10/2025 and 01/2028. Distribution was to a single customer who received product in California and Oklahoma.

Consumers who have affected product should follow the instructions issued by the distributor.

The recalled product

Product
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
Affected units
185,482

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by GMP Laboratories of America Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · GMP Laboratories of America Inc

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