Recall archive / FDA food enforcement
a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% pac... — FDA record H-0441-2025
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
- Classification
- Class III
- Recalling firm
- Aceto US, L.L.C
- Quantity
- 9%: 6033.45 Kg; 4%: 4485.95 Kg
- Agency-reported status
- Terminated
- Source record identifier
- H-0441-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 20, 2025
- Recall initiation date
- Jun 24, 2025
- Center classification date
- Aug 8, 2025
- Termination date
- Jul 31, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.