Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product description
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Lot numbers, UPCs & expiration codes
Lot: 241069C, Exp 05/31/2027
Where it was sold
Nationwide in the USA
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-0522-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 21, 2026
- FDA report date
- May 13, 2026
- Quantity
- 165,761 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0522-2026, exactly as published.
Show all FDA fields
- City
- Berkeley Heights
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98803
- Address
- 200 Connell Dr Ste 4200
- Code information
- Lot: 241069C, Exp 05/31/2027
- Postal code
- 07922-2805
- Report date
- May 13, 2026
- Product type
- Drugs
- Recall number
- D-0522-2026
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product quantity
- 165,761 90-count 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, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 21, 2026
- Initial firm notification
- Letter
- Center classification date
- May 6, 2026