a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a recall
Recalled by Aceto US, L.L.C · Port Washington, NY, United States
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
See the recall's own reason text for the specifics. All other reasons recalls.
What was recalled
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
Quantity: 9%: 6033.45 Kg; 4%: 4485.95 Kg
Lot codes, dates and UPCs
A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.
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
Where it was sold
Arizona California Florida Montana North Carolina New Jersey New York Utah
FDA's distribution note: NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Low risk, but check. Class III means the product is unlikely to make anyone ill but breaks an FDA rule, often a labeling one. If your package matches, the store will normally refund it. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
- Recalling firm
- Aceto US, L.L.C
- Initiated by
- Voluntary: Firm initiated
- Recall initiated
- Jun 24, 2025
- In FDA report of
- Aug 20, 2025
- Terminated
- Jul 31, 2026
- FDA recall number
- H-0441-2025 · event 97147
- Official record
- FDA enforcement report search