Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules
- Recalling company
- Breckenridge Pharmaceutical, Inc.
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
- Reason
- CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 9, 2025
- Reported
- Nov 5, 2025
- Distribution
- U.S. Nationwide
- Status
- Ongoing
- Quantity
- 172,263 bottles
- Lot / codes
- 90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
- Company location
- Berkeley Heights, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0100-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0100-2026 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.