Duloxetine capsules recalled over nitrosamine impurity above the safety assessment limit
Breckenridge Pharmaceutical is recalling 172,263 bottles of Duloxetine Delayed-Release Capsules 60 mg because N-nitroso-duloxetine was above the 12.5 ppm safety assessment limit.
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: Scored 3 under the risk-of-harm criterion: a named nitrosamine impurity above its stated safety assessment limit is a defined threshold breach, with no injuries reported.
Plain-English summary
Duloxetine Delayed-Release Capsules, USP, 60 mg, manufactured by Towa Pharmaceutical Europe of Martorelles, Barcelona, Spain and distributed by Breckenridge Pharmaceutical, are being recalled for CGMP deviations. Both the 90-count bottle (NDC 51991-748-90) and the 1,000-count bottle (NDC 51991-748-10) are affected.
The N-nitroso-duloxetine impurity was above the safety assessment limit of 12.5 ppm.
The recall covers 172,263 bottles: 90-count lot 240721C (expiring 28 February 2027) and 1,000-count lot 230286C (expiring 28 February 2026). The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Duloxetine is a prescription medicine, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Antidepressant
- Affected units
- 172,263
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 (3)
- 90-count- Lot # 240721C
- Exp. 02/28/2027 1000-count- Lot #230286C
- Exp.02/28/2026
Distribution
Distributed nationwide across the United States.
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