Actylis brand Lithium Orotate ingredient products were manufactured out of specification with incorrect potency levels. Products labeled as 4% and 9% contain only 3% and 4.45% respectively, failing to meet labeled strength.
Class III — Eating this product is not likely to cause health problems, but it violates FDA labelling or manufacturing rules.
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
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
| Recall # | Product | Lot / code | Status |
|---|---|---|---|
| H-0441-2025 | 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 | 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 | Completed |
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