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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
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 23, 2026 at 11:04 PM UTC.
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