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

FDA recall notice · announced August 20, 2025 · Aceto Us

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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%

Notes

Distribution: NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Lot/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
Quantity: 9%: 6033.45 Kg; 4%: 4485.95 Kg
Status: Completed
Products in this recall event:
- 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 (H-0441-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.