Prescription Duloxetine Capsules Recalled for Nitrosamine Impurity
Breckenridge Pharmaceutical is recalling Duloxetine 30 mg capsules distributed nationwide due to a nitrosamine impurity above acceptable limits. Consumers should consult their doctor about their medication.
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 a Class II FDA recall for a manufacturing deviation involving an impurity above the recommended limit. No illnesses or injuries have been reported, making this a theoretical risk-of-harm situation that qualifies as High severity per the rubric.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 30 mg (NDC 51991-747-10). The product is supplied in bottles of 1,000 capsules and was manufactured by Towa Pharmaceutical Europe, S.L., located in Martorelles, Barcelona, Spain.
The recall is due to a CGMP (good manufacturing practice) deviation. The deviation involves the presence of N-nitroso-duloxetine, a nitrosamine drug substance related impurity (NDSRI), at levels above the FDA's recommended interim limit.
The affected product (Lot 240909C, expiration date 03/31/2027) was distributed nationwide in the United States. Approximately 14,863 bottles are involved in this recall.
Consumers taking this medication should contact their pharmacist or healthcare provider for guidance regarding whether to continue using their current supply.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Antidepressant
- Hazard
- Affected units
- 14,863
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 240909C
- Exp Date 03/31/2027
Distribution
Distributed nationwide across the United States.
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