Class IIOngoing

Duloxetine Delayed-Release Capsules recall

FDA recall D-0583-2026 · initiated Jun 4, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: 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.
Recalling company: Breckenridge
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Jun 4, 2026
FDA report date: Jun 17, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0583-2026 ↗

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