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FDA recall record

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

Recall H-0441-2025Class IIITerminatedJune 24, 2025

FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.

FDA listed a termination date of July 31, 2026. openFDA does not treat this as a live recall-status tracker.

Product described in an FDA recall

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%

Products involved

Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.

  • 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

Code information listed by FDA

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 and firm information

Recalling firm listed by FDA: Aceto US, L.L.C

Firm location listed by FDA: Port Washington, NY, United States

Distribution reported by FDA: NJ, NC, CA, UT, MT, FL, AZ, NC, NY

Product quantity listed by FDA: 9%: 6033.45 Kg; 4%: 4485.95 Kg

Source

Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.

Official FDA openFDA food enforcement record

Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.