Recalls / Class II
Class IID-0552-2025
Product
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, 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: 230836C, Exp.: 02/28/2026
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Connell Dr Ste 4200, N/A, Berkeley Heights, New Jersey 07922-2805
Distribution
- Quantity
- 1,829 60-count bottles
- Distribution pattern
- U.S Nationwide
Timeline
- Recall initiated
- 2025-07-15
- FDA classified
- 2025-08-01
- Posted by FDA
- 2025-08-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0552-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.