Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules
- Recalling company
- Breckenridge Pharmaceutical, Inc.
- 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.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 24, 2025
- Reported
- Dec 10, 2025
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 7389 bottles
- Lot / codes
- Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
- Company location
- Berkeley Heights, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0216-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0216-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.