FDA Recall D-0621-2025

Breckenridge Pharmaceutical, Inc. · Berkeley Heights, NJ

Class II Ongoing 279 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, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10

Lot / code: Lot 240927C, Exp 04/30/2027

Quantity: 3,591 bottles

Reason for recall

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Recall record

Recall number: D-0621-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: AZ, IN, NJ
Recall initiated: 2025-08-08
Classified by FDA Center: 2025-09-08
FDA published: 2025-09-17
Recalling firm: Breckenridge Pharmaceutical, Inc.
Firm location: Berkeley Heights, NJ

Drug identification

Brand name(s): DULOXETINE
Generic name(s): DULOXETINE HYDROCHLORIDE
Manufacturer(s): Quallent Pharmaceuticals Health, LLC
NDC(s): 82009-029, 82009-030, 82009-032, 82009-031
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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