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

[pending] a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lith

Pending LLM rewrite. Source: FDA_FOOD H-0441-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

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

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