Duloxetine 30mg Capsules Recalled Due to Nitrosamine Impurity
Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.
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: FDA Class II recall of a prescription drug containing N-nitroso-duloxetine impurity above FDA-recommended limits. N-nitroso compounds are potentially genotoxic, constituting a risk-of-harm situation where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Hydrochloride 30mg delayed-release capsules distributed nationwide in the United States. The recall affects 163,883 bottles (NDC 51991-747-90, 90-count bottles) manufactured by Towa Pharmaceutical Europe in Spain. The affected lot number is 222205C with an expiration date of November 2025.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Specifically, N-nitroso-duloxetine impurity was detected above the FDA-recommended interim limit. N-nitroso compounds are known to be potentially genotoxic.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug
- Hazard
- Affected units
- 163,883
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 # 222205C
- exp. date 11/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Breckenridge Pharmaceutical, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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Similar recalls
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FDA (Drugs) · 2025-04-09
- HighDuloxetine Capsules Recalled for N-Nitroso Impurity Exceeding FDA Limits
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