FDAFDA · Food and drugs·Recall number D-0621-2025
Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10
Published September 17, 2025 · Recall initiated: August 8, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Distributor
- AZ, IN, NJ
- Lot
- Lot 240927C, Exp 04/30/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.