Official recall notice
FDA DrugClass IIINotable
FDA Recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx o
- Recall date
- 2026-08-05
- Category
- Drug
- FDA class
- Class III
Why it was recalled
Hazard
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
Product description
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
Affected products
Lot: 25141585, Exp. April 30, 2027.