Duloxetine 30mg Delayed-Release Capsules Recalled for N-Nitroso Impurity
Breckenridge Pharmaceutical recalls 14,749 bottles of duloxetine 30mg delayed-release capsules due to N-nitroso impurity above FDA safety limits. Patients taking this medication should contact their healthcare provider to verify if their prescription is affected.
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 is an FDA Class II recall of a prescription drug with a manufacturing impurity (N-nitroso compound) exceeding the agency's interim safety limit, representing a risk-of-harm situation. No illnesses, injuries, or deaths have been reported, limiting the score to 3 per the rubric.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling duloxetine delayed-release capsules, 30mg, in 1000-count bottles (NDC 51991-747-10). The affected lot is 240225C with expiration date January 2027.
The recall was initiated due to a current good manufacturing practices (CGMP) deviation: the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim safety limit.
The affected product was distributed nationwide, with approximately 14,749 bottles of the recalled lot in distribution.
Patients currently taking duloxetine should contact their healthcare provider or pharmacist to determine whether their prescription matches the recalled lot number (240225C). Do not abruptly discontinue the medication without medical guidance.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Affected units
- 14,749
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#: 240225C
- Expiration: 01/2027
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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