# FDA drug recall: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-7

> recall · VERIFIED · 2026-06-04

Firm: Breckenridge Pharmaceutical, Inc. · Class II · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

- Company: Breckenridge Pharmaceutical, Inc.
- Sector: pharma
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.
