Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., M
Summary
The FDA issued a recall for Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Man by Ascend Laboratories, LLC. Reason: Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test ana.
Details
Source
Drug Recall
External ID
N/A
Action Date
2026-08-05
Status
Ongoing
Category
drug
Product Description
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Lot/Code Info: Lot: 25141586, Exp. April 30, 2027.
Quantity Affected: 936 cartons x 12 x 3 x 10 (in blister pack)
Reason for Recall
Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities
Distribution
Within the U.S Market.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-16
Company
Bedminster, NJ
Context & Analysis
This is a unclassified recall.
This was one of 35 drug recalls issued in the same week, part of 63 drug-related FDA actions this month.
Ascend Laboratories, LLC has 34 FDA actions in our database, including 34 recalls.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ascend Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ascend Laboratories, LLC have FDA actions?
Ascend Laboratories, LLC has 34 FDA actions in our database, including 34 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "N/A" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22