[pending] DULOXETINE (DULOXETINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0582-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 241180C
- Exp. Date April 2027.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DULOXETINE
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FDA (Drugs) · 2026-05-13
- ModerateDuloxetine Delayed-Release Capsules Recalled for Impurity Above Limit
FDA (Drugs) · 2026-05-13
- ModerateDuloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit
FDA (Drugs) · 2026-05-13
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- HighPrescription Duloxetine Capsules Recalled for Nitrosamine Impurity
FDA (Drugs) · 2025-04-09
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