Duloxetine delayed-release capsules exceed the interim limit for a nitrosamine impurity
Duloxetine Delayed-Release Capsules 40 mg are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 12,242 bottles are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA's named interim limit, with no injury reported in the source.
Plain-English summary
Duloxetine Delayed-Release Capsules, USP, 40 mg, 30-count bottles, prescription only, manufactured by Towa Pharmaceutical Europe, S.L. of Martorelles, Barcelona, Spain and distributed by Breckenridge Pharmaceuticals, Inc. of Berkeley Heights, New Jersey, are being recalled. The action covers 12,242 30-count bottles.
The stated reason is CGMP deviations: the presence of N-nitroso-duloxetine impurity above the FDA recommended interim limit. The FDA classified the action as Class II.
The affected lot is 230199, expiring 01/31/2026. Distribution was nationwide in the United States.
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
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 # 230199
- Exp. Date 01/31/2026
Distribution
Distributed nationwide across the United States.
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