Class II

Drug Recall: 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

Ascend Laboratories, LLC · December 12, 2024

Reason for Recall

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

1971 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0129-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.