Recall notice
Actylis Lithium Orotate products recalled due to Incorrect Concentration Levels, USA
5 months ago •source accessdata.fda.gov
United States
Aceto US, L.L.C. has initiated a voluntary recall of its Actylis brand Lithium Orotate products due to incorrect concentration levels. The products were distributed across several states, including New Jersey, North Carolina, California, Utah, Montana, Florida, Arizona, and New York in the United States.AFFECTED PRODUCTS:
PRODUCT: Actylis brand Lithium Orotate 4%
- Packaged in: HDPE Liner in a 25kg carton
- SKU: TLIOR0104
- Lot: T250464; T250265; T250184; T240967; T240619; T240452; T240346; T230944; T20230304
- Product Quantity: 4,485.95 Kg
- Reason for recall: 4% Lithium Orotate product may only contain 3%
PRODUCT: Actylis brand Lithium Orotate 9%
- Packaged in: HDPE Liner in a 25kg carton
- SKU: TLIOR0109
- Lot: T250409; T250353; T250310; T250124; T241240; T240936; T240560; T240125; T20230223; T20230403; T20220701; T20221002; T20221204
- Product Quantity: 6,033.45 Kg
- Reason for recall: 9% Lithium Orotate product may contain 4.45%
The issue was discovered through internal quality checks. This recall is classified as Class III and was initiated on June 24, 2025, with the classification date on August 8, 2025. The recall is currently ongoing.
Source: www.accessdata.fda.gov/scripts/ires/index.cfm
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