a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packa
Summary
The FDA issued a Class III for a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b. by Aceto US, L.L.C. Reason: 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%.
Details
Source
Food Recall
External ID
H-0441-2025
Action Date
2025-08-20
Status
Ongoing
Category
food
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
Lot/Code Info: 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
Quantity Affected: 9%: 6033.45 Kg; 4%: 4485.95 Kg
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-24
Company
Port Washington, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 113 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aceto US, L.L.C) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aceto US, L.L.C have FDA actions?
This is the only FDA action we have on record for Aceto US, L.L.C in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0441-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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