FDA Recall D-0100-2026

Breckenridge Pharmaceutical, Inc. · Berkeley Heights, NJ

Class II Ongoing 217 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, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.

Lot / code: 90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026

Quantity: 172,263 bottles

Reason for recall

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Recall record

Recall number: D-0100-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-10-09
Classified by FDA Center: 2025-10-24
FDA published: 2025-11-05
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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