Class IIITerminatedVoluntary: Firm initiated
Aceto US, L.L.C: food recall H-0441-2025
Aceto US, L.L.C of Port Washington, NY recalled a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9%… Reason: 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%. The FDA listed it as Class III in its Enforcement Report dated Aug 20, 2025; distribution: Arizona, California, Florida, Montana, North Carolina, New Jersey, New York, Utah.
Record status as published: Terminated (terminated Jul 31, 2026). openFDA data last updated Oct 21, 2026.
Have this product? Check FDA.gov and your retailer. This page reproduces an FDA Enforcement Report record and is not a public alert. Look for the firm's recall notice on the FDA's recalls page, or ask the store where you bought it what to do. If you think you got sick from a food, contact a health care provider.
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
- Product quantity
- 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%
- Codes, lots and dates on the package
- 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 pattern
- NJ, NC, CA, UT, MT, FL, AZ, NC, NY
- Recalling firm
- Aceto US, L.L.C, Port Washington, NY
- Classification
- Class III — the FDA uses this class for a situation in which using or being exposed to the product is not likely to cause adverse health consequences.
- Voluntary or mandated
- Voluntary: Firm initiated
- How the firm first notified customers
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Dates
| Event | Date |
|---|---|
| Recall initiated by the firm | Jun 24, 2025 |
| Classified by the FDA | Aug 8, 2025 |
| Published in the Enforcement Report | Aug 20, 2025 |
| Terminated | Jul 31, 2026 |
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Sources
- U.S. Food and Drug Administration, openFDA food enforcement reports, recall number H-0441-2025 (openFDA record). Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).
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