Medications & Supplements/Prescription Drugs

Aurobindo Pharma Limited (Unit I): Irbesartan Active Ingredient Recalled for Carcinogenic Impurity (NDEA)

Agency Publication Date: October 31, 2018

Summary

Aurobindo Pharma Limited is recalling approximately 1,725 units (totaling 1,724.8 kilograms) of Irbesartan Bulk Active Pharmaceutical Ingredient. This bulk ingredient, which is used to manufacture blood pressure medication, was found to contain N-Nitrosodimethylamine (NDEA), a substance classified as a probable human carcinogen. The recall was initiated after testing detected the presence of this impurity in the active ingredient produced at the company's facility in India. While this recall involves bulk material distributed to a pharmaceutical manufacturer rather than finished tablets directly to consumers, it affects the safety of the final medication produced from these batches.

Risk

The product is contaminated with N-Nitrosodimethylamine (NDEA), which is a known environmental contaminant and a probable human carcinogen. Long-term exposure to levels of NDEA above acceptable limits may increase the risk of developing cancer.

What You Should Do

Identify if your medication is affected by checking for these specific manufacturing batch numbers: 1601100782, 1601100783, 1701111861, 1701112170, 1701112501, 1701112056, 1701112558, 1701112559, 1701112589, 1701113300, 1701113301, 1701113302, 1701113312, 1701115460, 1701115974, 1701115738, 1701115739, 1701115740, 1701115741, or 1701115742.
Check the expiration dates on your medication packaging for dates including 12/01/2018, 09/01/2020, 10/01/2020, or 11/01/2020.
Contact your healthcare provider or pharmacist immediately for guidance if you believe your medication was made using these affected bulk lots. Do not stop taking your medication without a replacement, as the risk of harm to your health from stopping blood pressure medication may be higher than the risk of the impurity.
Return any unused or affected medication to your pharmacy for a refund and contact Aurobindo Pharma Limited for further instructions regarding the return process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return unused product to place of purchase.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Irbesartan Bulk Active Pharmaceutical Ingredient (1724.8 kgs.)

Model:

D-0127-2019

Lot Numbers:

Batch 1601100782 / Dispatch 1601101589

Batch 1601100783 / Dispatch 1601101590

Batch 1701111861 / Dispatch 1701113404

Batch 1701112170 / Dispatch 1701113405

Batch 1701112501 / Dispatch 1701113406

Batch 1701112056 / Dispatch 1701113407

Batch 1701112558 / Dispatch 1701114283

Batch 1701112559 / Dispatch 1701114285

Batch 1701112589 / Dispatch 1701114286

Batch 1701113300 / Dispatch 1701114289

Batch 1701113301 / Dispatch 1701114291

Batch 1701113302 / Dispatch 1701114708

Batch 1701113312 / Dispatch 1701114709

Batch 1701115460 / Dispatch 1701117039

Batch 1701115974 / Dispatch 1701117040

Batch 1701115460 / Dispatch 1701117041

Batch 1701115738 / Dispatch 1701117042

Batch 1701115739 / Dispatch 1701117043

Batch 1701115740 / Dispatch 1701117044

Batch 1701115741 / Dispatch 1701117045

Batch 1701115742 / Dispatch 1701117046

Date Ranges: Exp. 12/01/2018, Exp. 09/01/2020, Exp. 10/01/2020, Exp. 11/01/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81442

Status: Resolved

Manufacturer: Aurobindo Pharma Limited (Unit I)

Sold By: Bulk pharmaceutical customer

Manufactured In: India

Units Affected: 1724.8 kgs.

Distributed To: New York

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

Identify if your medication is affected by checking for these specific manufacturing batch numbers: 1601100782, 1601100783, 1701111861, 1701112170, 1701112501, 1701112056, 1701112558, 1701112559, 1701112589, 1701113300, 1701113301, 1701113302, 1701113312, 1701115460, 1701115974, 1701115738, 1701115739, 1701115740, 1701115741, or 1701115742.

Check the expiration dates on your medication packaging for dates including 12/01/2018, 09/01/2020, 10/01/2020, or 11/01/2020.

Contact your healthcare provider or pharmacist immediately for guidance if you believe your medication was made using these affected bulk lots. Do not stop taking your medication without a replacement, as the risk of harm to your health from stopping blood pressure medication may be higher than the risk of the impurity.

Return any unused or affected medication to your pharmacy for a refund and contact Aurobindo Pharma Limited for further instructions regarding the return process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Irbesartan Bulk Active Pharmaceutical Ingredient (1724.8 kgs.)

Model:

D-0127-2019

Lot Numbers:

Batch 1601100782 / Dispatch 1601101589

Batch 1601100783 / Dispatch 1601101590

Batch 1701111861 / Dispatch 1701113404

Batch 1701112170 / Dispatch 1701113405

Batch 1701112501 / Dispatch 1701113406

Batch 1701112056 / Dispatch 1701113407

Batch 1701112558 / Dispatch 1701114283

Batch 1701112559 / Dispatch 1701114285

Batch 1701112589 / Dispatch 1701114286

Batch 1701113300 / Dispatch 1701114289

Batch 1701113301 / Dispatch 1701114291

Batch 1701113302 / Dispatch 1701114708

Batch 1701113312 / Dispatch 1701114709

Batch 1701115460 / Dispatch 1701117039

Batch 1701115974 / Dispatch 1701117040

Batch 1701115460 / Dispatch 1701117041

Batch 1701115738 / Dispatch 1701117042

Batch 1701115739 / Dispatch 1701117043

Batch 1701115740 / Dispatch 1701117044

Batch 1701115741 / Dispatch 1701117045

Batch 1701115742 / Dispatch 1701117046

Date Ranges: Exp. 12/01/2018, Exp. 09/01/2020, Exp. 10/01/2020, Exp. 11/01/2020