Why it was recalled
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
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 numbers, UPCs & expiration 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 sold
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- H-0441-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 24, 2025
- FDA report date
- Aug 20, 2025
- Quantity
- 9%: 6033.45 Kg; 4%: 4485.95 Kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aceto US, L.L.C
Original FDA data
Every field from FDA enforcement report H-0441-2025, exactly as published.
Show all FDA fields
- City
- Port Washington
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 97147
- Address
- 4 Tri Harbor Ct
- Code information
- 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
- Postal code
- 11050-4661
- Report date
- Aug 20, 2025
- Product type
- Food
- Recall number
- H-0441-2025
- Classification
- Class III
- Recalling firm
- Aceto US, L.L.C
- Product quantity
- 9%: 6033.45 Kg; 4%: 4485.95 Kg
- Termination date
- Jul 31, 2026
- Reason for recall
- 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- NJ, NC, CA, UT, MT, FL, AZ, NC, NY
- Recall initiation date
- Jun 24, 2025
- Initial firm notification
- Center classification date
- Aug 8, 2025