a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand L...

FDA Recall #H-0441-2025 — Class III — June 24, 2025

Recall #H-0441-2025 Date: June 24, 2025 Classification: Class III Status: Ongoing

Product Description

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%

Recalling Firm

Aceto US, L.L.C — Port Washington, NY

Classification

Class III — A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Product Type

Food

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated