Direct Rx: Duloxetine D/r, A) 30 Mg
Direct Rx is recalling duloxetine 30 mg capsules (both 30-count and 60-count bottles) distributed nationwide because the medication contains higher-than-acceptable levels of N-nitroso-duloxetine, a potentially harmful impurity. The affected products were packaged and distributed by Direct Rx under both their own label and the Cymbalta brand name. This is a Class II recall, meaning the product could cause adverse health effects.
- Recalling firm
- Direct Rx
- Product
- DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
- 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
- 2026-06-22
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/aff94202-98aa-4a82-9cd9-4d5e0ca89358