LOW RISK
Completed
H-0441-2025
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
Recalled by Aceto US, L.L.C
Classification
Class III — Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.
Reason for Recall
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Product Details
Product Quantity
9%: 6033.45 Kg; 4%: 4485.95 Kg
Product Type
Food
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
Voluntary/Mandated
Voluntary: Firm initiated
Distribution & Geography
Distribution Pattern
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Company Location
Port Washington, NY, 11050-4661
Timeline
Report Date
08/20/2025
Recall Initiated
06/24/2025
Classification Date
08/08/2025
Termination Date
N/A
Source: U.S. Food & Drug Administration (FDA) — FDA Recalls
Last updated: July 13, 2026
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