Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules
- Recalling company
- Breckenridge Pharmaceutical, Inc.
- Product
- Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 4, 2026
- Reported
- Jun 17, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 14,729 bottles.
- Lot / codes
- Lot: 241180C, Exp. Date April 2027.
- Company location
- Berkeley Heights, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0582-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0582-2026 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.