Prescription drug duloxetine recalled for chemical impurity above FDA limits
Breckenridge Pharmaceutical is recalling duloxetine 60 mg capsules due to N-nitroso-duloxetine impurity exceeding FDA recommended limits. Approximately 1,856 bottles distributed to New Jersey, Arizona, and Indiana.
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 classified this as a Class II recall, reflecting potential for serious adverse health consequences. N-nitroso-duloxetine is a recognized genotoxic impurity; its presence above FDA recommended limits in a prescription medication represents a risk-of-harm product.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg (NDC 82009-032-10), manufactured by Towa Pharmaceutical Europe, S.L. in Spain. The affected lot is 240539C with an expiration date of January 31, 2027. Approximately 1,856 bottles were distributed to healthcare facilities and pharmacies.
The recall was initiated due to a manufacturing quality defect. Testing identified the presence of N-nitroso-duloxetine impurity in excess of FDA recommended interim limits. This is a Class II FDA recall, indicating a reasonable possibility of serious adverse health consequences.
The affected product was distributed in New Jersey, Arizona, and Indiana.
Patients currently taking this medication should continue their use unless instructed otherwise by their healthcare provider. Pharmacists and healthcare providers should quarantine affected inventory and contact their suppliers for return or replacement. Patients or healthcare providers with questions should contact Breckenridge Pharmaceutical or their healthcare provider.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug
- 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 240539C
- Exp 1/31/2027
Distribution
Distributed in 3 states:
- AZ
- IN
- NJ
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