Drug FDA Class II Ongoing cGMP deviation

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 Published Dec 18, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Ascend Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

N-nitroso-Dabigatran · primary

Affected products (1)

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

DABIGATRAN ETEXILATE · 1971 bottles

NDC: 67877-474, 67877-475, 67877-624, 67877-475-60, 67877-474-60, 67877-624-60, 67877-624-31

Code info: Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.

Affected areas

Nationwide

Timeline

Initiated

Dec 12, 2024
Published

Dec 18, 2024

Recall number: D-0129-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.