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Food FDA Class III Ongoing Mislabeling

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

Aceto US, L.L.C Published Aug 20, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 35/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Aceto US, L.L.C or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

9%: 6033.45 Kg; 4%: 4485.95 Kg

Lot codes: Numbers
Code info: 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; T20221204

Affected areas

ArizonaCaliforniaFloridaMontanaNew JerseyNew YorkNorth CarolinaUtah

Timeline

  1. Initiated
    Jun 24, 2025
  2. Published
    Aug 20, 2025
Recall number
H-0441-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA food enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.