FDA DrugClass IIINotable
FDA Recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx o
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
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
Remedy
924 cartons x 12 x 6 x 10 (in blister pack)
Related Recalls
2026-08-05 · FDA_DRUG
FDA Recall: Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx
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2026-08-05 · FDA_DRUG
FDA Recall: Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx
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2026-07-29 · FDA_DRUG
FDA Recall: Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Labor
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2026-07-29 · FDA_DRUG
FDA Recall: Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Labor
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