Prescription antidepressant drug recalled for elevated N-nitroso-duloxetine impurity
Breckenridge Pharmaceutical is recalling Duloxetine 40mg capsules nationwide due to manufacturing deviations that resulted in elevated N-nitroso-duloxetine impurity above FDA limits.
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 drug recall for presence of N-nitroso-duloxetine impurity above FDA interim limit due to CGMP deviations. Meets rubric Score 3 as a risk-of-harm product where injury has not been reported.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine 40mg delayed-release capsules due to manufacturing issues. The recall affects approximately 12,242 bottles in 30-count packages with lot number 230199 and expiration date January 31, 2026 (NDC 51991-750-33). The product was distributed nationwide throughout the United States.
The recall is due to current good manufacturing practice (CGMP) deviations identified in the manufacturing process. Specifically, the product contains N-nitroso-duloxetine impurity at levels exceeding the FDA's recommended interim limit.
Patients taking Duloxetine should check their medication bottle to determine if they have the affected lot by looking for lot number 230199. Those with the affected medication should contact their healthcare provider.
For additional information about this recall, consumers may contact Breckenridge Pharmaceutical, Inc. or the FDA.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Hazard
- n-nitroso-impurity
- manufacturing-defect
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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