Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product description
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Lot numbers, UPCs & expiration codes
Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 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-0583-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 4, 2026
- FDA report date
- Jun 17, 2026
- Quantity
- 359,676 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0583-2026, exactly as published.
Show all FDA fields
- City
- Berkeley Heights
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99108
- Address
- 200 Connell Dr Ste 4200
- Code information
- Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.
- Postal code
- 07922-2805
- Report date
- Jun 17, 2026
- Product type
- Drugs
- Recall number
- D-0583-2026
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product quantity
- 359,676 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, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 4, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2026