FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled May 13, 2026

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

Hazard: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0522-2026
Brand
Breckenridge Pharmaceutical
Classification
Class II
Units affected
165,761 90-count bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

Affected products

Companies & origin

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

Identifying details (verbatim from the notice)

Product codes / lots
Lot: 241069C, Exp 05/31/2027
Distribution
Nationwide in the USA
Firm notified the public via
Letter
FDA event ID
98803
Recall initiated
April 21, 2026
FDA classified
May 6, 2026
FDA report date
May 13, 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 23, 2026 at 11:04 PM UTC.

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