FDA recall D-0738-2026

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 for recall

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

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2026-07-16

Report date

2026-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0738-2026