Recalls / Class II
Class IID-0308-2025
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
- 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 240909C, Exp Date 03/31/2027
Why it was recalled
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Connell Dr Ste 4200, Berkeley Heights, New Jersey 07922-2805
Distribution
- Quantity
- 14,863 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-03-26
- FDA classified
- 2025-04-01
- Posted by FDA
- 2025-04-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0308-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.