FDA recall H-0441-2025

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%

Distribution

NJ, NC, CA, UT, MT, FL, AZ, NC, NY

Key facts

Status

Ongoing

Initiation date

2025-06-24

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Port Washington, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0441-2025