FDARecalled Dec 10, 2025 · #D-0216-2026
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Phar...
Hazard
Class II — temporary health risk
Be the first to hear about future recalls.
Add the things you own to a watchlist. We’ll alert you the moment one matches.
Get started, freeDescription
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Classification: Class II Distribution: Nationwide within the United States
Product details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Model numbers
- 240534C
- UPCs
- —