Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Amlodipine and Valsartan Products Recalled for NDEA Impurity

Agency Publication Date: January 14, 2019

Summary

Aurobindo Pharma USA Inc. is recalling 495,000 bottles of various blood pressure and heart medication products, including Amlodipine, Valsartan, and Hydrochlorothiazide combinations. Testing by the FDA confirmed that the active pharmaceutical ingredient (API) used to manufacture these tablets contained an impurity called N-nitrosodimethylamine (NDEA) at levels exceeding acceptable safety standards. This recall involves several dosage strengths and packaging sizes distributed nationwide through 25 major distributors and retail chains.

Risk

NDEA is classified as a probable human carcinogen, meaning long-term exposure to levels above the interim acceptable limit of 0.083 parts per million may increase the risk of cancer.

What You Should Do

Check your prescription bottles to identify if your medication is part of this recall by comparing the product name, NDC number, and lot number printed on the label.
For Amlodipine and Valsartan USP 5 mg/160 mg (30-count, NDC 65862-737-30), look for lot numbers VESA17013-A, VESA17014-A (Exp 10/2019), VESA18001-A, or VESA18002-A (Exp 12/2019).
For Amlodipine and Valsartan USP 10 mg/160 mg (30-count, NDC 65862-739-30), look for lot numbers including VFSA17008-A through VFSA18008-A and VKSA17008-A through VKSA18004-A with expirations ranging from May 2019 to March 2020.
For Valsartan and Hydrochlorothiazide USP 320 mg/25 mg (90-count, NDC 65862-551-90), check for 24 specific lot numbers including HTSB17049-A through HTSB18029-A with expiration dates between August 2020 and March 2021.
Do NOT stop taking your medication before talking to your doctor or pharmacist, as the risk of harm to your health from stopping a blood pressure medication suddenly may be higher than the risk of exposure to the impurity.
Contact your healthcare provider or pharmacist for guidance on obtaining a replacement medication or alternative treatment, and return any unused product to the pharmacy for a refund.
Contact the manufacturer, Aurobindo Pharma USA Inc., for further instructions at their headquarters in East Windsor, New Jersey.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

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

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

Affected Products

Product: Amlodipine and Valsartan Tablets USP 5 mg/160 mg (30-count bottles)

Model:

NDC 65862-737-30

Lot Numbers:

VESA17013-A (Exp 10/2019)

VESA17014-A (Exp 10/2019)

VESA18001-A (Exp 12/2019)

VESA18002-A (Exp 12/2019)

Date Ranges: 10/2019, 12/2019

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

Model:

NDC 65862-739-30

Lot Numbers:

VFSA17008-A (Exp 10/2019)

VFSA17010-A (Exp 10/2019)

VFSA18002-A (Exp 01/2020)

VFSA18003-A (Exp 01/2020)

VFSA18007-A (Exp 03/2020)

VFSA18008-A (Exp 03/2020)

VKSA17008-A (Exp 05/2019)

VFSA17009-A (Exp 10/2019)

VKSA17014-A (Exp 10/2019)

VKSA17015-A (Exp 10/2019)

VKSA17016-A (Exp 10/2019)

VKSA17017-A (Exp 10/2019)

VKSA18002-A (Exp 01/2020)

VKSA18004-A (Exp 01/2020)

Date Ranges: 05/2019, 10/2019, 01/2020, 03/2020

Product: Amlodipine and Valsartan Tablets USP 5 mg/320 mg (30-count bottles)

Model:

NDC 65862-738-30

Lot Numbers:

VMSA17012-A (Exp 11/2019)

VMSA17013-A (Exp 11/2019)

VMSA17014-A (Exp 11/2019)

VMSA17015-A (Exp 11/2019)

VMSA17016-A (Exp 11/2019)

VMSA17017-A (Exp 11/2019)

Date Ranges: 11/2019

Product: Amlodipine and Valsartan Tablets USP 10 mg/320 mg (30-count bottles)

Model:

NDC 65862-740-30

Lot Numbers:

VKSA18005-A (Exp 03/2020)

VKSA18001-A (Exp 01/2020)

Date Ranges: 01/2020, 03/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg (90-count bottles)

Model:

NDC 65862-550-90

Lot Numbers:

HRSA17033-A (Exp 10/2020)

HRSA17034-A (Exp 10/2020)

HRSA17035-A (Exp 10/2020)

HRSA17036-A (Exp 10/2020)

HRSA17037-A (Exp 10/2020)

Date Ranges: 10/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg (90-count bottles)

Model:

NDC 65862-548-90

Lot Numbers:

HTSA17033-A (Exp 10/2020)

HTSA17034-A (Exp 10/2020)

HTSA17035-A (Exp 10/2020)

HTSA17036-A (Exp 10/2020)

HTSA17040-A (Exp 10/2020)

HTSA17041-A (Exp 11/2020)

HTSA17042-A (Exp 11/2020)

HTSA17043-A (Exp 11/2020)

HTSA17037-A (Exp 10/2020)

HTSA17039-A (Exp 10/2020)

Date Ranges: 10/2020, 11/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg (90-count bottles)

Model:

NDC 65862-551-90

Lot Numbers:

HTSB17049-A (Exp 08/2020)

HTSB17054-A (Exp 10/2020)

HTSB17055-A (Exp 10/2020)

HTSB17056-A (Exp 10/2020)

HTSB17057-A (Exp 10/2020)

HTSB17058-A (Exp 10/2020)

HTSB17059-A (Exp 10/2020)

HTSB17060-A (Exp 10/2020)

HTSB17062-A (Exp 10/2020)

HTSB17066-A (Exp 10/2020)

HTSB17067-A (Exp 11/2020)

HTSB17068-A (Exp 11/2020)

HTSB17069-A (Exp 11/2020)

HTSB18001-A (Exp 12/2020)

HTSB18002-A (Exp 12/2020)

HTSB18003-A (Exp 12/2020)

HTSB18004-A (Exp 12/2020)

HTSB18005-A (Exp 12/2020)

HTSB18006-A (Exp 12/2020)

HTSB18007-A (Exp 12/2020)

HTSB17063-A (Exp 10/2020)

HTSB17064-A (Exp 10/2020)

HTSB17065-A (Exp 10/2020)

HTSB18029-A (Exp 03/2021)

Date Ranges: 08/2020, 10/2020, 11/2020, 12/2020, 03/2021

Product: Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg (90-count bottles)

Model:

NDC 65862-547-90

Lot Numbers:

HVSA17011-A (Exp 11/2020)

HVSA17012-A (Exp 11/2020)

HVSA18001-A (Exp 12/2020)

Date Ranges: 11/2020, 12/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg (90-count bottles)

Model:

NDC 65862-549-90

Lot Numbers:

HVSB17023-A (Exp 08/2020)

HVSB17036-A (Exp 11/2020)

HVSB17037-A (Exp 11/2020)

HVSB17038-A (Exp 11/2020)

HVSB17039-A (Exp 11/2020)

HVSB17040-B (Exp 11/2020)

HVSB18001-A (Exp 12/2020)

HVSB18002-A (Exp 12/2020)

HVSB18003-A (Exp 12/2020)

HVSB18004-A (Exp 12/2020)

Date Ranges: 08/2020, 11/2020, 12/2020

Product: Valsartan tablets USP 320 mg (90-count bottles)

Model:

NDC 65862-573-90

Lot Numbers:

VUSD17008-A (Exp 07/2019)

VUSD17009-A (Exp 09/2019)

Date Ranges: 07/2019, 09/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81887

Status: Active

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: distributors; Retail Chains

Manufactured In: United States

Units Affected: 10 products (18,408 bottles; 60,417 bottles; 27,688 bottles; 55,788 bottles; 23,016 bottles; 92,616 bottles; 111,239 bottles; 32,160 bottles; 53,064 bottles; 20,604 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

Check your prescription bottles to identify if your medication is part of this recall by comparing the product name, NDC number, and lot number printed on the label.

For Amlodipine and Valsartan USP 5 mg/160 mg (30-count, NDC 65862-737-30), look for lot numbers VESA17013-A, VESA17014-A (Exp 10/2019), VESA18001-A, or VESA18002-A (Exp 12/2019).

For Amlodipine and Valsartan USP 10 mg/160 mg (30-count, NDC 65862-739-30), look for lot numbers including VFSA17008-A through VFSA18008-A and VKSA17008-A through VKSA18004-A with expirations ranging from May 2019 to March 2020.

For Valsartan and Hydrochlorothiazide USP 320 mg/25 mg (90-count, NDC 65862-551-90), check for 24 specific lot numbers including HTSB17049-A through HTSB18029-A with expiration dates between August 2020 and March 2021.

Do NOT stop taking your medication before talking to your doctor or pharmacist, as the risk of harm to your health from stopping a blood pressure medication suddenly may be higher than the risk of exposure to the impurity.

Contact your healthcare provider or pharmacist for guidance on obtaining a replacement medication or alternative treatment, and return any unused product to the pharmacy for a refund.

Contact the manufacturer, Aurobindo Pharma USA Inc., for further instructions at their headquarters in East Windsor, New Jersey.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Amlodipine and Valsartan Tablets USP 5 mg/160 mg (30-count bottles)

Model:

NDC 65862-737-30

Lot Numbers:

VESA17013-A (Exp 10/2019)

VESA17014-A (Exp 10/2019)

VESA18001-A (Exp 12/2019)

VESA18002-A (Exp 12/2019)

Date Ranges: 10/2019, 12/2019

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

Model:

NDC 65862-739-30

Lot Numbers:

VFSA17008-A (Exp 10/2019)

VFSA17010-A (Exp 10/2019)

VFSA18002-A (Exp 01/2020)

VFSA18003-A (Exp 01/2020)

VFSA18007-A (Exp 03/2020)

VFSA18008-A (Exp 03/2020)

VKSA17008-A (Exp 05/2019)

VFSA17009-A (Exp 10/2019)

VKSA17014-A (Exp 10/2019)

VKSA17015-A (Exp 10/2019)

VKSA17016-A (Exp 10/2019)

VKSA17017-A (Exp 10/2019)

VKSA18002-A (Exp 01/2020)

VKSA18004-A (Exp 01/2020)

Date Ranges: 05/2019, 10/2019, 01/2020, 03/2020

Product: Amlodipine and Valsartan Tablets USP 5 mg/320 mg (30-count bottles)

Model:

NDC 65862-738-30

Lot Numbers:

VMSA17012-A (Exp 11/2019)

VMSA17013-A (Exp 11/2019)

VMSA17014-A (Exp 11/2019)

VMSA17015-A (Exp 11/2019)

VMSA17016-A (Exp 11/2019)

VMSA17017-A (Exp 11/2019)

Date Ranges: 11/2019

Product: Amlodipine and Valsartan Tablets USP 10 mg/320 mg (30-count bottles)

Model:

NDC 65862-740-30

Lot Numbers:

VKSA18005-A (Exp 03/2020)

VKSA18001-A (Exp 01/2020)

Date Ranges: 01/2020, 03/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg (90-count bottles)

Model:

NDC 65862-550-90

Lot Numbers:

HRSA17033-A (Exp 10/2020)

HRSA17034-A (Exp 10/2020)

HRSA17035-A (Exp 10/2020)

HRSA17036-A (Exp 10/2020)

HRSA17037-A (Exp 10/2020)

Date Ranges: 10/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg (90-count bottles)

Model:

NDC 65862-548-90

Lot Numbers:

HTSA17033-A (Exp 10/2020)

HTSA17034-A (Exp 10/2020)

HTSA17035-A (Exp 10/2020)

HTSA17036-A (Exp 10/2020)

HTSA17040-A (Exp 10/2020)

HTSA17041-A (Exp 11/2020)

HTSA17042-A (Exp 11/2020)

HTSA17043-A (Exp 11/2020)

HTSA17037-A (Exp 10/2020)

HTSA17039-A (Exp 10/2020)

Date Ranges: 10/2020, 11/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg (90-count bottles)

Model:

NDC 65862-551-90

Lot Numbers:

HTSB17049-A (Exp 08/2020)

HTSB17054-A (Exp 10/2020)

HTSB17055-A (Exp 10/2020)

HTSB17056-A (Exp 10/2020)

HTSB17057-A (Exp 10/2020)

HTSB17058-A (Exp 10/2020)

HTSB17059-A (Exp 10/2020)

HTSB17060-A (Exp 10/2020)

HTSB17062-A (Exp 10/2020)

HTSB17066-A (Exp 10/2020)

HTSB17067-A (Exp 11/2020)

HTSB17068-A (Exp 11/2020)

HTSB17069-A (Exp 11/2020)

HTSB18001-A (Exp 12/2020)

HTSB18002-A (Exp 12/2020)

HTSB18003-A (Exp 12/2020)

HTSB18004-A (Exp 12/2020)

HTSB18005-A (Exp 12/2020)

HTSB18006-A (Exp 12/2020)

HTSB18007-A (Exp 12/2020)

HTSB17063-A (Exp 10/2020)

HTSB17064-A (Exp 10/2020)

HTSB17065-A (Exp 10/2020)

HTSB18029-A (Exp 03/2021)

Date Ranges: 08/2020, 10/2020, 11/2020, 12/2020, 03/2021

Product: Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg (90-count bottles)

Model:

NDC 65862-547-90

Lot Numbers:

HVSA17011-A (Exp 11/2020)

HVSA17012-A (Exp 11/2020)

HVSA18001-A (Exp 12/2020)

Date Ranges: 11/2020, 12/2020

Product: Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg (90-count bottles)

Model:

NDC 65862-549-90

Lot Numbers:

HVSB17023-A (Exp 08/2020)

HVSB17036-A (Exp 11/2020)

HVSB17037-A (Exp 11/2020)

HVSB17038-A (Exp 11/2020)

HVSB17039-A (Exp 11/2020)

HVSB17040-B (Exp 11/2020)

HVSB18001-A (Exp 12/2020)

HVSB18002-A (Exp 12/2020)

HVSB18003-A (Exp 12/2020)

HVSB18004-A (Exp 12/2020)

Date Ranges: 08/2020, 11/2020, 12/2020

Product: Valsartan tablets USP 320 mg (90-count bottles)

Model:

NDC 65862-573-90

Lot Numbers:

VUSD17008-A (Exp 07/2019)

VUSD17009-A (Exp 09/2019)

Date Ranges: 07/2019, 09/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81887

Status: Active

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: distributors; Retail Chains

Manufactured In: United States

Units Affected: 10 products (18,408 bottles; 60,417 bottles; 27,688 bottles; 55,788 bottles; 23,016 bottles; 92,616 bottles; 111,239 bottles; 32,160 bottles; 53,064 bottles; 20,604 bottles)

Distributed To: Nationwide