FDA Drugs recall ·
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only… recall
- Recall number
- D-0129-2025
- Date
- (initiated December 12, 2024)
- Company / brand
- Ascend Laboratories, LLC
339 Jefferson Rd Ste 101, Parsippany, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1971 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Why was it recalled?
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0129-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.