Recall Enforment Report D-0456-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Torrent Pharma Inc., originally initiated on 05-27-2025 for the product Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) The product was recalled due to cgmp deviations: presence of n-nitroso fluoxetine exceeding interim acceptable intake limit.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0456-202505-27-202506-11-2025Class II972 CartonsFluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.Ongoing
D-0455-202505-27-202506-11-2025Class II3672 BottlesFluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
13668-443Fluoxetine FluoxetineTabletOralTorrent Pharmaceuticals LimitedHuman Prescription Drug
13668-473Fluoxetine FluoxetineTabletOralTorrent Pharmaceuticals LimitedHuman Prescription Drug