The Recall Desk
ModerateFDA (Food)·H-0441-2025·Announced 2025-08-20

Actylis Brand Lithium Orotate Recalled for Lower Potency

Aceto US is recalling Actylis brand Lithium Orotate 4% and 9% products because the potency levels are lower than labeled. The 4% product contains only 3%, and the 9% product contains 4.45%.

What this means for you

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 with no reported illnesses or injuries. The issue is sub-potency—labeled 4% product contains only 3%, and labeled 9% product contains 4.45%—a labeling and composition variance with no direct safety hazard reported.

Plain-English summary

Aceto US, L.L.C is recalling Actylis brand Lithium Orotate products due to potency variance. The 4% formulation may contain only 3% Lithium Orotate, and the 9% formulation may contain 4.45% instead of the labeled 9%. This recall affects products distributed across multiple states: NJ, NC, CA, UT, MT, FL, AZ, and NY.

The affected products include specific lot numbers for both formulations. For the 4% product (SKU TLIOR0104), the affected lots are T250464, T250265, T250184, T240967, T240619, T240452, T240346, T230944, and T20230304. For the 9% product (SKU TLIOR0109), the affected lots are T250409, T250353, T250310, T250124, T241240, T240936, T240560, T240125, T20230223, T20230403, T20220701, T20221002, and T20221204.

Consumers or businesses who have purchased these products should stop using them and contact the manufacturer with questions. The total quantities affected are 4485.95 kg of the 4% formulation and 6033.45 kg of the 9% formulation.

The recalled product

Product
a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packaged in HDPE Liner in a 25kg carton
Manufacturer
Aceto US, L.L.C
Category
Drug — Supplement ingredient
Hazard
  • potency-variance
  • mis-labeling

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 (20)

  • a.) SKU: TLIOR0104 and Lot Numbers: T250464
  • T250265
  • T250184
  • T240967
  • T240619
  • T240452
  • T240346
  • T230944
  • T20230304 b.) SKU: TLIOR0109 and Lot Numbers: T250409
  • T250353
  • T250310
  • T250124
  • T241240
  • T240936
  • T240560
  • T240125
  • T20230223
  • T20230403
  • T20220701
  • T20221002

Distribution

Distributed in 8 states:

  • AZ
  • CA
  • FL
  • MT
  • NC
  • NJ
  • NY
  • UT

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