Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-release Capsules, Usp, 60mg
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 60mg in bottle sizes of 90 and 1000 capsules due to the presence of N-nitroso-duloxetine impurity above FDA-recommended limits. The affected medication was distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, indicating a potential health hazard, though the company identified the issue through manufacturing quality control deviations.
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product
- Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-04
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/7905e51b-3f5a-4980-8cbb-f3a7aa815737