Duloxetine delayed-release capsules recalled for manufacturing impurity exceeding limits
Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.
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: This FDA Class II recall involves N-nitroso-duloxetine, a geotoxic impurity, above FDA-recommended limits. This is a risk-of-harm product where injury has not been reported, fitting the High severity criterion.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine (duloxetine hydrochloride) delayed-release capsules, 20 mg, distributed nationwide. The product was manufactured by Towa Pharmaceutical Europe, S.L. in Barcelona, Spain and distributed by Breckenridge Pharmaceuticals, Inc. The affected medication is 500-count bottles (NDC 51991-746-05) with lot code 220456, expiring February 2025. Approximately 7,188 bottles have been distributed.
The recall was initiated due to the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. The impurity was identified during Good Manufacturing Practice (CGMP) investigations. N-nitroso-duloxetine is a genotoxic compound of potential health concern.
The affected product was distributed nationwide. Consumers and healthcare providers with affected medication should contact their pharmacist or Breckenridge Pharmaceutical for guidance. Patients should consult their healthcare provider regarding their medication management.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug
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 (1)
- 220456: Exp. Feb 2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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