Aceto US, L.L.C:
a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner… recall

FDASource reference: H-0441-2025
4% Lithium Orotate product may only c…

What to do

Do not eat, serve, or sell the affected product.

Confirm affected products and instructions on the official notice before acting.

Why it was recalled

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

Recall details

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
Brand
Aceto US, L.L.C
Reported
August 20, 2025
Status
Terminated
Distribution
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
Products / lots
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
Classification
Class III

Read the complete notice

The agency notice is the source for product identifiers, distribution, and any changes to the recall.

Archive records are not a statement about a product's current safety.