Recalls / Class II
Class IID-0216-2026
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 51991-746, 51991-747, 51991-748, 51991-750
- FDA application
- ANDA203088
- Affected lot / code info
- Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 200 Connell Dr Ste 4200, Berkeley Heights, New Jersey 07922-2805
Distribution
- Quantity
- 7389 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-11-24
- FDA classified
- 2025-12-03
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0216-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.