FDAClass II · Drug · Recalled June 17, 2026

Duloxetine Delayed-Release Capsules recall — Breckenridge Pharmaceutical, Inc.

Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0583-2026
Brand: Breckenridge Pharmaceutical
Classification: Class II
Units affected: 359,676 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Affected products

Duloxetine Delayed-Release Capsules

Companies & origin

Recalling firm location: Berkeley Heights, NJ, United States
Firm address: 200 Connell Dr Ste 4200, N/A, 07922-2805

Identifying details (verbatim from the notice)

Product codes / lots: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.
Distribution: Nationwide within the United States
Firm notified the public via: Letter
FDA event ID: 99108
Recall initiated: June 4, 2026
FDA classified: June 8, 2026
FDA report date: June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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