Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Lot numbers, UPCs & expiration codes
Lot#: 240225C, Expiration: 01/2027
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0270-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 28, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 14,749 bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0270-2025, exactly as published.
Show all FDA fields
- City
- Berkeley Heights
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96380
- Address
- 200 Connell Dr Ste 4200
- Code information
- Lot#: 240225C, Expiration: 01/2027
- Postal code
- 07922-2805
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0270-2025
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product quantity
- 14,749 bottles.
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 28, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 11, 2025