a — Class III food recall H-0441-2025
Terminated recall by Aceto US, L.L.C, reported 2025-08-20, distributed in AZ, CA, FL, MT, NC, NJ, NY, UT. 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
| Recall number | H-0441-2025 |
|---|---|
| Product type | Food |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aceto US, L.L.C, Port Washington, NY, United States |
| Recall initiated | 2025-06-24 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Terminated | 2026-07-31 |
| Distributed | AZ, CA, FL, MT, NC, NJ, NY, UT |
| Lot numbers | T20220701, T20221002, T20221204, T20230223, T20230304, T20230403, T230944, T240125, T240346, T240452, T240560, T240619, T240936, T240967, T241240, T250124, T250184, T250265, T250310, T250353, T250409, T250464 |
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
Reason for recall
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/H-0441-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.