[pending] DULOXETINE (DULOXETINE)
Pending LLM rewrite. Source: FDA_DRUG D-0555-2026.
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 Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
The recalled product
- Product
- DULOXETINE (DULOXETINE)
- Brand
- DULOXETINE
- Manufacturer
- Asclemed USA 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 # 050725G-30 & 050725F-30
- Exp Date: 06/30/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DULOXETINE
- ModerateDuloxetine Delayed-Release Capsules 20 mg Recalled for Impurity
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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