Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Valsartan and Amlodipine Tablets Recalled Due to Trace Impurity (NDEA)

Agency Publication Date: March 21, 2019

Summary

Aurobindo Pharma USA Inc. is recalling multiple lots of Valsartan and Amlodipine/Valsartan combination tablets used to treat high blood pressure. Testing by the FDA found trace amounts of N-nitrosodiethylamine (NDEA), a substance that occurs naturally in certain foods and drinking water but is classified as a probable human carcinogen. Consumers should not stop taking their medication without first speaking to their doctor, as the risk of stopping blood pressure treatment immediately can be higher than the risk of exposure to the impurity.

Risk

The tablets contain trace amounts of NDEA, an impurity that is considered a probable human carcinogen based on laboratory testing. Long-term exposure to this impurity above acceptable levels may increase the risk of developing cancer.

What You Should Do

Check your prescription bottle label to see if your medication is Valsartan or Amlodipine/Valsartan distributed by Aurobindo Pharma USA, Inc. with NDC numbers 65862-573-90, 65862-739-30, 65862-570-30, 65862-571-90, or 65862-572-90.
Identify if your lot number and expiration date are affected: For Valsartan 320mg (90ct), check for lots 473180004A, 473180005A (Feb 2020), 473180006A (Mar 2020), 473180016A, 473180017A (May 2020), or 473170019A (Oct 2019).
For Amlodipine/Valsartan 10mg/160mg (30ct), check for lot VFSA17007-A (Oct-2019). For Valsartan 40mg (30ct), check for lots 470180008A (Feb 2020), 470180014A, 470180016A (Mar 2020), or 470180032A (May 2020).
For Valsartan 80mg (90ct), check for lots 471170015A (Sep 2019), 471180004A, or 471180005A (Feb 2019). For Valsartan 160mg (90ct), check for lots 472180001A through 472180004A (Jan 2020), 472180007A through 472180010A (Mar 2020), or 472180013A, 472180014A (Apr 2020).
Contact your healthcare provider or pharmacist immediately if you have an affected lot to discuss an alternative treatment; do NOT stop taking the medication until you have a replacement, as untreated high blood pressure poses immediate health risks.
Return any affected unused product to your pharmacy for a refund and contact Aurobindo Pharma USA Inc. at their East Windsor, NJ location for further guidance.
Contact the FDA Consumer Complaint hotline for additional questions at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Valsartan Tablets USP 320 mg (90 count bottles)

Model:

NDC 65862-573-90

Lot Numbers:

473180004A (Exp Feb 2020)

473180005A (Exp Feb 2020)

473180006A (Exp Mar 2020)

473180016A (Exp May 2020)

473180017A (Exp May 2020)

473170019A (Exp Oct 2019)

Product: Amlodipine and Valsartan Tablets USP 10mg/160mg (30 count bottles)

Model:

NDC 65862-739-30

Lot Numbers:

VFSA17007-A (Exp Oct-2019)

Product: Valsartan Tablets USP 40 mg (30 count bottles)

Model:

NDC 65862-570-30

Lot Numbers:

470180008A (Exp Feb 2020)

470180014A (Exp Mar 2020)

470180016A (Exp Mar 2020)

470180032A (Exp May 2020)

Product: Valsartan Tablets USP 80 mg (90 count bottles)

Model:

NDC 65862-571-90

Lot Numbers:

471170015A (Exp Sep 2019)

471180004A (Exp Feb 2019)

471180005A (Exp Feb 2019)

Product: Valsartan Tablets USP 160 mg (90 count bottles)

Model:

NDC 65862-572-90

Lot Numbers:

472180001A (Exp Jan 2020)

472180002A (Exp Jan 2020)

472180003A (Exp Jan 2020)

472180004A (Exp Jan 2020)

472180007A (Exp Mar 2020)

472180008A (Exp Mar 2020)

472180009A (Exp Mar 2020)

472180010A (Exp Mar 2020)

472180013A (Exp Apr 2020)

472180014A (Exp Apr 2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82114

Status: Active

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: major distribution chains

Manufactured In: United States, India

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

Check your prescription bottle label to see if your medication is Valsartan or Amlodipine/Valsartan distributed by Aurobindo Pharma USA, Inc. with NDC numbers 65862-573-90, 65862-739-30, 65862-570-30, 65862-571-90, or 65862-572-90.

Identify if your lot number and expiration date are affected: For Valsartan 320mg (90ct), check for lots 473180004A, 473180005A (Feb 2020), 473180006A (Mar 2020), 473180016A, 473180017A (May 2020), or 473170019A (Oct 2019).

For Amlodipine/Valsartan 10mg/160mg (30ct), check for lot VFSA17007-A (Oct-2019). For Valsartan 40mg (30ct), check for lots 470180008A (Feb 2020), 470180014A, 470180016A (Mar 2020), or 470180032A (May 2020).

For Valsartan 80mg (90ct), check for lots 471170015A (Sep 2019), 471180004A, or 471180005A (Feb 2019). For Valsartan 160mg (90ct), check for lots 472180001A through 472180004A (Jan 2020), 472180007A through 472180010A (Mar 2020), or 472180013A, 472180014A (Apr 2020).

Contact your healthcare provider or pharmacist immediately if you have an affected lot to discuss an alternative treatment; do NOT stop taking the medication until you have a replacement, as untreated high blood pressure poses immediate health risks.

Return any affected unused product to your pharmacy for a refund and contact Aurobindo Pharma USA Inc. at their East Windsor, NJ location for further guidance.

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

Affected Products

Product: Valsartan Tablets USP 320 mg (90 count bottles)

Model:

NDC 65862-573-90

Lot Numbers:

473180004A (Exp Feb 2020)

473180005A (Exp Feb 2020)

473180006A (Exp Mar 2020)

473180016A (Exp May 2020)

473180017A (Exp May 2020)

473170019A (Exp Oct 2019)

Product: Amlodipine and Valsartan Tablets USP 10mg/160mg (30 count bottles)

Model:

NDC 65862-739-30

Lot Numbers:

VFSA17007-A (Exp Oct-2019)

Product: Valsartan Tablets USP 40 mg (30 count bottles)

Model:

NDC 65862-570-30

Lot Numbers:

470180008A (Exp Feb 2020)

470180014A (Exp Mar 2020)

470180016A (Exp Mar 2020)

470180032A (Exp May 2020)

Product: Valsartan Tablets USP 80 mg (90 count bottles)

Model:

NDC 65862-571-90

Lot Numbers:

471170015A (Exp Sep 2019)

471180004A (Exp Feb 2019)

471180005A (Exp Feb 2019)

Product: Valsartan Tablets USP 160 mg (90 count bottles)

Model:

NDC 65862-572-90

Lot Numbers:

472180001A (Exp Jan 2020)

472180002A (Exp Jan 2020)

472180003A (Exp Jan 2020)

472180004A (Exp Jan 2020)

472180007A (Exp Mar 2020)

472180008A (Exp Mar 2020)

472180009A (Exp Mar 2020)

472180010A (Exp Mar 2020)

472180013A (Exp Apr 2020)

472180014A (Exp Apr 2020)