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.
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: 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.
Related recalls
Same brand · DULOXETINE
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighEnovachem duloxetine capsules exceed the nitrosamine acceptable intake limit
FDA (Drugs) · 2026-06-10
- ModerateDuloxetine Delayed-Release Capsules Recalled for Impurity Above Limit
FDA (Drugs) · 2026-05-13
- ModerateDuloxetine Delayed-Release Capsules 20 mg Recalled for Impurity
FDA (Drugs) · 2026-05-13
Same manufacturer · Breckenridge Pharmaceutical, Inc.
See all →- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- HighDuloxetine delayed-release capsules recalled over a nitrosamine impurity above FDA limits
FDA (Drugs) · 2025-12-10
- HighIntelliVue MX550 patient monitors recalled over an alarm activation issue
FDA (Drugs) · 2025-12-10
- HighDuloxetine delayed-release capsules recalled over N-nitroso-duloxetine above interim limit
FDA (Drugs) · 2025-09-17
- HighQuallent duloxetine 60 mg capsules exceed the interim nitrosamine limit
FDA (Drugs) · 2025-08-20
Same hazard · nitrosamine
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- HighClomipramine 25 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12
- HighClomipramine 50 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12
- HighClomipramine 75 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12