Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Lot numbers, UPCs & expiration codes
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Where it was sold
Nationwide within the United States
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-0216-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 24, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 7389 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0216-2026, exactly as published.
Show all FDA fields
- City
- Berkeley Heights
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98034
- Address
- 200 Connell Dr Ste 4200
- Code information
- Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
- Postal code
- 07922-2805
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0216-2026
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product quantity
- 7389 bottles
- Reason for recall
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 24, 2025
- Center classification date
- Dec 3, 2025