Food recall

Aceto US, L.L.C recall: a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9%...

Aceto US, L.L.C, of Port Washington, NY, recalled a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9%.... The FDA's reason: “4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on June 24, 2025, and the FDA first listed it in its Enforcement Report of August 20, 2025. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

See FDA's words below

Status

Terminated

Closed July 31, 2026

The recall

Company
Aceto US, L.L.C (Port Washington, NY)
Reason, in FDA's words
“4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%”
Where it was sold
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
97147

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • H-0441-2025 Class III

    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

    Codes: 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

    Quantity: 9%: 6033.45 Kg; 4%: 4485.95 Kg

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of August 20, 2025.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.