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Aceto US, L.L.C
FDA recall H-0441-2025 · Class III · reported 2025-08-20 · Terminated
- 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
- 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
- Quantity
- 9%: 6033.45 Kg; 4%: 4485.95 Kg
- Distribution
- NJ, NC, CA, UT, MT, FL, AZ, NC, NY
- Firm location
- NY, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Recall started
- 2025-06-24
- Terminated
- 2026-07-31
- 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
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.