Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-release Capsules, Usp, 30mg, 1000 Capsule Bottles
Recall Summary Breckenridge Pharmaceutical is recalling 1,000-capsule bottles of Duloxetine Delayed-Release Capsules 30mg due to higher-than-acceptable levels of an impurity called N-nitroso-duloxetine. The affected medication was manufactured by Towa Pharmaceutical Europe in Spain and distributed nationwide across all U.S. states. This is a Class II recall, meaning the product could cause adverse health effects.
- Recalling firm
- 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
- 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/64c2b432-9434-422c-b12e-1179694445da