Ascend Laboratories, LLC 2026-08-05 Health moderate FDA
Health · FDA · Recall #FDA-D-0738-2026
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a… Recall
Issued August 5, 2026 · Ascend Laboratories, LLC
In August 2026, Ascend Laboratories, LLC recalled the Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a…, a moderate health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ascend Laboratories, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Ascend Laboratories, LLC
- Category
- Health
- Recall date
- August 5, 2026
- Units affected
- Not reported
- Sold at
- USA Nationwide
- Recall number
- FDA-D-0738-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Ascend Laboratories, LLC has 15 recalls in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.