Drug recall D-0215-2026
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Reason for recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots and codes
Lot #: 240947C, 240962C, Exp. Date 04/2027
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Quantity
- 3397 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 24, 2025
Related products
- Duloxetine – drug information
- NDC 82009-032 Duloxetine · Duloxetine Hydrochloride 60 mg/1 · Quallent Pharmaceuticals Health, LLC
- NDC 82009-030 Duloxetine · Duloxetine Hydrochloride 30 mg/1 · Quallent Pharmaceuticals Health, LLC
- NDC 82009-031 Duloxetine · Duloxetine Hydrochloride 40 mg/1 · Quallent Pharmaceuticals Health, LLC
- NDC 82009-029 Duloxetine · Duloxetine Hydrochloride 20 mg/1 · Quallent Pharmaceuticals Health, LLC