Prescription Duloxetine Recalled for Impurity Above FDA Limits
Breckenridge Pharmaceutical recalls duloxetine capsules due to manufacturing deviations resulting in N-nitroso-duloxetine impurity above FDA recommended levels. The recall affects 7,389 bottles distributed nationwide.
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 involving manufacturing deviations with chemical impurity above FDA recommended limits. No illnesses or injuries are reported in the source, so this is assessed as High (3) rather than Severe (4), as it represents a risk-of-harm product without yet-reported harm.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg in 1,000-capsule bottles due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because testing identified N-nitroso-duloxetine impurity in affected lots at levels exceeding FDA recommendations.
Affected products include two lots: Lot #240534C (expiration 01/2027) and Lot #240977C (expiration 04/2027). Approximately 7,389 bottles were distributed nationwide in the United States. The product was manufactured by Towa Pharmaceuticals Europe, S.L. in Martorell, Barcelona, Spain, and distributed by Breckenridge Pharmaceutical Inc., Berkeley Heights, New Jersey.
Consumers who are taking duloxetine from affected lots should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication without consulting a healthcare professional. Patients should check their medication bottles for the lot number and expiration date to determine if their supply is affected.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Antidepressant
- Hazard
- manufacturing-defect
- n-nitroso-impurity
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 #: 240534C
- Exp. Date 01/2027
- 240977C
- Exp. Date 04/2027.
Distribution
Distributed nationwide across the United States.
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