FDA Recall D-0308-2025

Breckenridge Pharmaceutical, Inc. · Berkeley Heights, NJ

Class II Ongoing 414 days on record

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

Product

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

Lot / code: Lot 240909C, Exp Date 03/31/2027

Quantity: 14,863 bottles

Reason for recall

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Recall record

Recall number: D-0308-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2025-03-26
Classified by FDA Center: 2025-04-01
FDA published: 2025-04-09
Recalling firm: Breckenridge Pharmaceutical, Inc.
Firm location: Berkeley Heights, NJ

Drug identification

Brand name(s): DULOXETINE
Generic name(s): DULOXETINE HYDROCHLORIDE
Manufacturer(s): Breckenridge Pharmaceutical, Inc.
NDC(s): 51991-746, 51991-747, 51991-748, 51991-750
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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