Aceto US recalls a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a: label issue
Find the official FDA enforcement report
Recall at a glance
- Recalling company
- Aceto US
- Location
- Port Washington, NY
- Reported by FDA
- August 20, 2025
- Recall started
- June 24, 2025
- Risk class
- Class III
- Status (latest data we have)
- Terminated
- Type
- Voluntary: Firm initiated
- Category
- Other foods
- Reason type
- Labeling and quality
Is my product affected?
Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.
- 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
Quantity: 9%: 6033.45 Kg; 4%: 4485.95 Kg
Codes: 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
Where it was distributed
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
What to do
If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.
Frequently asked questions
What was recalled?
Aceto US recalled 1 product, including a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packaged in HDPE Liner….
Why was it recalled?
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
What does Class III mean?
FDA’s lowest-risk class: use of the product is not likely to cause adverse health consequences.
Where was it sold or shipped?
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
What should I do if I have this product?
Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.
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Sources
Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.