Prescription Drug Duloxetine Recalled for Nitrosamine Impurity Exceeding FDA Limits
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.
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: FDA Class II recall due to detected N-nitroso-duloxetine impurity exceeding FDA recommended interim limits. No illnesses or injuries have been reported. The hazard is based on manufacturing quality deviation, not reported adverse effects.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP 60mg (90-count bottles) distributed nationwide in the United States. The recall affects approximately 165,678 bottles with lot numbers 230035C (expiration 11/30/2025) and 230101C (expiration 12/31/2025), manufactured by Towa Pharmaceutical Europe in Spain.
The recall was initiated due to the presence of N-nitroso-duloxetine impurity at levels exceeding the FDA's recommended interim limit. This impurity was identified during current good manufacturing practice (CGMP) quality testing.
Duloxetine is a prescription antidepressant used to treat major depressive disorder, generalized anxiety disorder, and other conditions. Patients currently taking this medication should not stop without consulting their healthcare provider, as abruptly discontinuing may cause adverse effects.
Consumers with affected bottles should contact their pharmacy or healthcare provider for guidance. The product is identified by NDC 51991-748-90. No illnesses or adverse events have been reported as of this recall announcement.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Antidepressant
- Hazard
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 (4)
- Lot #: 230035C
- Exp. date 11/30/2025
- 230101C
- Exp. date 12/31/2025
Distribution
Distributed nationwide across the United States.
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