Recalls / Class II
Class IID-0580-2025
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 82009-029, 82009-030, 82009-032, 82009-031
- FDA application
- ANDA203088
- Affected lot / code info
- Lot 240539C, Exp 1/31/2027
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc.
- Manufacturer
- Quallent Pharmaceuticals Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Connell Dr Ste 4200, N/A, Berkeley Heights, New Jersey 07922-2805
Distribution
- Quantity
- 1,856 bottles
- Distribution pattern
- NJ, AZ, IN
Timeline
- Recall initiated
- 2025-07-25
- FDA classified
- 2025-08-12
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0580-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.