Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-release Capsules Usp, 60mg
Recall Summary Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules USP 60mg (90-count bottles) distributed nationwide because the medication contains higher-than-acceptable levels of N-nitroso-duloxetine impurity, which resulted from manufacturing deviations. This is a Class II recall affecting patients who received this antidepressant medication across all U.S. states and Washington, D.C.
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product
- Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-21
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/7e9698b3-67ce-442d-abac-75c0fc6220a9