Recall RadarDabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: M…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
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
- Ascend Laboratories, LLC — Bedminster, NJ
- Severity
- Class III — low
- Reported
- August 5, 2026
- Quantity
- 924 cartons x 12 x 6 x 10 (in blister pack)
- Recall number
- D-0738-2026
- Status
- Ongoing
- Source
- FDA
Where it went
USA Nationwide
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