H-0441-2025 Class III Terminated
FDA food recall H-0441-2025 was initiated by Aceto US, L.L.C on June 24, 2025 and is designated Class III. Reason for recall: 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45% The recall status is terminated (terminated July 31, 2026). Affected quantity: 9%: 6033.45 Kg; 4%: 4485.95 Kg.
Recall Details
- Product Type
- Food
- Report Date
- August 20, 2025
- Initiation Date
- June 24, 2025
- Termination Date
- July 31, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9%: 6033.45 Kg; 4%: 4485.95 Kg
Product Description
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%
Distribution Pattern
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Code Information
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