Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product description
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
Lot numbers, UPCs & expiration codes
Lot 240539C, Exp 1/31/2027
Where it was sold
NJ, AZ, IN
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-0580-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 25, 2025
- FDA report date
- Aug 20, 2025
- Quantity
- 1,856 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0580-2025, exactly as published.
Show all FDA fields
- City
- Berkeley Heights
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97336
- Address
- 200 Connell Dr Ste 4200
- Code information
- Lot 240539C, Exp 1/31/2027
- Postal code
- 07922-2805
- Report date
- Aug 20, 2025
- Product type
- Drugs
- Recall number
- D-0580-2025
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product quantity
- 1,856 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, 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
- Distribution pattern
- NJ, AZ, IN
- Recall initiation date
- Jul 25, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2025