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FDA recalls · H-0441-2025

Aceto US, L.L.C recall

  • Fooda.) 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
  • Reason4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
  • ClassClass III: the food is unlikely to cause health problems
  • StatusClosed by FDA, ended 2026-07-31
  • DatesFirm started it 2025-06-24. In FDA's enforcement report 2025-08-20.
  • Sold inNJ, NC, CA, UT, MT, FL, AZ, NC, NY
  • Amount9%: 6033.45 Kg; 4%: 4485.95 Kg
  • Codesa.) 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
  • FirmAceto US, L.L.C, Port Washington, NY · Voluntary: Firm initiated

Products we list

None. We tie a recall to a product only by a barcode printed in the recall, and this one names none we list. That does not mean the recalled food is missing from our listings.

From FDA's enforcement report, via openFDA (CC0): raw data for this recall. FDA's own Enforcement Report search finds it by its number, H-0441-2025. Class meanings: FDA.