Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Product description
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
Lot numbers, UPCs & expiration codes
Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
Where it was sold
US 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-0388-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 14, 2025
- FDA report date
- Apr 30, 2025
- Quantity
- 343,344 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-0388-2025, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Ongoing
- Country
- United States
- Event ID
- 96707
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
- Postal code
- 06037-2352
- Report date
- Apr 30, 2025
- Product type
- Drugs
- Recall number
- D-0388-2025
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 343,344 bottles
- Reason for recall
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Apr 14, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 22, 2025