Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine
Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.
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: Risk-of-harm product: a nitrosamine impurity measured above the named safety assessment limit, with no injury reported in the source.
Plain-English summary
Duloxetine Delayed-Release Capsules, USP, 60 mg, prescription only, manufactured by Towa Pharmaceutical Europe, S.L. of Martorelles, Barcelona, Spain and distributed by Breckenridge Pharmaceuticals, Inc. of Berkeley Heights, New Jersey, is being recalled. The action covers 1,829 60-count bottles.
The stated reason is CGMP deviations: the presence of N-nitroso-duloxetine impurity above the safety assessment limit. The FDA classified the action as Class II.
The affected lot is 230836C, expiring 02/28/2026. Distribution was nationwide in the US.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Delayed-release capsule
- Hazard
- nitrosamine
- n-nitroso-duloxetine
- impurity-limit
- cgmp-deviation
- class-ii
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: 230836C
- Exp.: 02/28/2026
Distribution
Distributed nationwide across the United States.
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