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 · H-0441-2025 · published 2025-08-20

FDA campaign H-0441-2025

Class III

Hazard

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

REKALLD area-alert coverage: AZ, CA, FL, MT, NC, NJ, NY, UT (our reading of the distribution above)

The text above is quoted verbatim from the FDA record. Confirm the affected units and the remedy with the manufacturer or FDA. Recall data may be incomplete, delayed, or superseded.

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Affected products

Aceto US, L.L.C

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

Brands in this recall

Aceto US, L.L.C