Class III
Ongoing
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
This recall is currently active, issued August 20, 2025. It was issued by Aceto Us, L.L.C.
- Company
- Aceto Us, L.L.C
- Recall Initiated
- June 24, 2025
- Posted
- August 20, 2025
- Recall Number
- H-0441-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9%: 6033.45 Kg; 4%: 4485.95 Kg
- Firm Location
- Port Washington, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Distribution
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Lot / 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
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