Duloxetine Delayed-release Capsules, Usp, 60 Mg, 1000-capsule Bottles, Rx Only, Manufactured By: Towa Pharmaceuticals Europe, S.l. Marotrelles, (barcelona), Spain, Distributed By: Breckenridge Pharmac
Breckenridge Pharmaceutical is recalling 1000-capsule bottles of Duloxetine Delayed-Release Capsules, 60 mg, distributed nationwide, because the medication contains higher levels of an impurity called N-nitroso-duloxetine than FDA guidelines allow. The impurity resulted from manufacturing issues at the Spanish facility that produced the drug. This is a Class I recall, the most serious classification.
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-24
- 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/9ef67b3b-704d-4a3d-be79-e5966dfeea5c