RecallRadar

FDA Drug recall D-0735-2026

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…

On 2026-07-29 the FDA classified a Class III recall of Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:… by Ascend Laboratories, citing failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testi….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0735-2026
ClassificationClass III
Statusongoing
Initiated2026-06-30
Published2026-07-29
Last updated2026-09-13 11:52 UTC
CompanyAscend Laboratories
DistributionUS

Product

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

Reason

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term 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: 25141707, Exp 4/30/2027.

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-0735-2026%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.