Recall RadarDULOXETINE 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.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Direct Rx — Dawsonville, GA
- Severity
- Class II — moderate
- Reported
- July 1, 2026
- Quantity
- 263 Bottles
- Recall number
- D-0617-2026
- Status
- Ongoing
- Source
- FDA
Where it went
U.S. Nationwide
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