FDA Recall D-0455-2025

Torrent Pharma Inc. · Basking Ridge, NJ

Class II Ongoing 352 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Fluoxetine 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: 13668-473-30

Lot / code: Lot# BDX6K001; Exp. Date 06/30/2025

Quantity: 3672 Bottles

Reason for recall

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Recall record

Recall number: D-0455-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: U.S. Nationwide.
Recall initiated: 2025-05-27
Classified by FDA Center: 2025-06-02
FDA published: 2025-06-11
Recalling firm: Torrent Pharma Inc.
Firm location: Basking Ridge, NJ

Drug identification

Brand name(s): FLUOXETINE
Generic name(s): FLUOXETINE
Manufacturer(s): Torrent Pharmaceuticals Limited
NDC(s): 13668-443, 13668-473
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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