FDA Food Low 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

Reported: August 20, 2025 Initiated: June 24, 2025 #H-0441-2025

Product Description

Reason for Recall

4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

Details

Recalling Firm: Aceto US, L.L.C
Units Affected: 9%: 6033.45 Kg; 4%: 4485.95 Kg
Distribution: NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Location: Port Washington, NY

Frequently Asked Questions

What product 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. Recalled by Aceto US, L.L.C. Units affected: 9%: 6033.45 Kg; 4%: 4485.95 Kg.

Why was this product recalled? ▼

4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

Which agency issued this recall? ▼

This recall was issued by the FDA Food on August 20, 2025. Severity: Low. Recall number: H-0441-2025.