Medications & Supplements/Prescription Drugs

Dabigatran Etexilate Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: December 12, 2024

Summary

Ascend Laboratories, LLC is recalling 12,415 bottles of Dabigatran Etexilate capsules (75 mg and 150 mg strengths). Dabigatran Etexilate is a prescription blood thinner used to prevent strokes and blood clots. This recall was initiated because certain batches were found to contain N-nitroso-dabigatran, an impurity that exceeds the recommended safe limit. The affected products were manufactured by Alkem Laboratories Ltd. in India and distributed nationwide in 60-count bottles.

Risk

N-nitroso-dabigatran is a type of nitrosamine, which is a substance that may increase the risk of cancer if people are exposed to it above acceptable levels over a long period of time.

What You Should Do

This recall affects Dabigatran Etexilate 75 mg and 150 mg capsules sold in 60-count bottles under the Ascend Laboratories, LLC brand.
Check your medication bottle for NDC codes 67877-474-60 or 67877-475-60. You should also check the lot number and expiration date printed on the label. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information about this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dabigatran Etexilate (75 mg)

Variants: 75 mg capsules, 60-count bottles

Lot Numbers:

24142328 (Exp. May 31, 2026)

24142329 (Exp. May 31, 2026)

24142330 (Exp. May 31, 2026)

NDC:

67877-474-60

Manufactured by Alkem Laboratories Ltd., INDIA

Product: Dabigatran Etexilate (150 mg)

Variants: 150 mg capsules, 60-count bottles

Lot Numbers:

24142192 (Exp. April 30, 2026)

24142193 (Exp. April 30, 2026)

24142194 (Exp. April 30, 2026)

24142463 (Exp. May 31, 2026)

NDC:

67877-475-60

Manufactured by Alkem Laboratories Ltd., INDIA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95896

Status: Active

Manufacturer: Ascend Laboratories, LLC

Sold By: Retail Pharmacies

Manufactured In: India

Units Affected: 2 products (1971 bottles; 10,444 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Dabigatran Etexilate 75 mg and 150 mg capsules sold in 60-count bottles under the Ascend Laboratories, LLC brand.

Check your medication bottle for NDC codes 67877-474-60 or 67877-475-60. You should also check the lot number and expiration date printed on the label. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information about this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dabigatran Etexilate (75 mg)

Variants: 75 mg capsules, 60-count bottles

Lot Numbers:

24142328 (Exp. May 31, 2026)

24142329 (Exp. May 31, 2026)

24142330 (Exp. May 31, 2026)

NDC:

67877-474-60

Manufactured by Alkem Laboratories Ltd., INDIA

Product: Dabigatran Etexilate (150 mg)

Variants: 150 mg capsules, 60-count bottles

Lot Numbers:

24142192 (Exp. April 30, 2026)

24142193 (Exp. April 30, 2026)

24142194 (Exp. April 30, 2026)

24142463 (Exp. May 31, 2026)

NDC:

67877-475-60

Manufactured by Alkem Laboratories Ltd., INDIA