FDA Food recall ·

a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg… recall

Recall number
H-0441-2025
Date
(initiated June 24, 2025)
Company / brand
Aceto US, L.L.C
4 Tri Harbor Ct, Port Washington, NY, United States
Category
Food › Class III
Classification
Class III
Status
Terminated
Units affected
9%: 6033.45 Kg; 4%: 4485.95 Kg
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

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

States: Arizona California Florida Montana North Carolina New Jersey New York Utah

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (food), recall H-0441-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.