RecallRadar

FDA Drug recall D-0738-2026

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie…

On 2026-08-05 the FDA classified a Class III recall of Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie… by Ascend Laboratories, citing 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 Drug notice

AgencyFDA Drug
Recall numberD-0738-2026
ClassificationClass III
Statusongoing
Initiated2026-07-16
Published2026-08-05
Last updated2026-09-13 11:52 UTC
CompanyAscend Laboratories
DistributionUS

Product

Dabigatran 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: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

Reason

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

Identifiers

ndc0904-7253-35
ndc0904-7253-04
ndc0904-7253-68
ndc0904-7254-35
ndc0904-7254-68
ndc0904-7255-35
ndc0904-7255-10
ndc0904-7255-68
code_infoLot: 25141585, Exp. April 30, 2027.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0738-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.