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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Torrent Pharma Inc.: Valsartan and Amlodipine Combination Tablets Recalled for Carcinogen Impurity

Agency Publication Date: August 28, 2018
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Summary

Torrent Pharma Inc. is recalling 634,092 bottles of various blood pressure medications, including Valsartan and Amlodipine combination tablets, because a carcinogen impurity was detected in the active ingredient. The recall includes multiple strengths and combinations of these prescription drugs used to treat hypertension. Consumers using these medications should continue taking them until they have spoken with a healthcare professional, as the risk of stopping the medication suddenly may be greater than the risk of the impurity.

Risk

The medications contain an impurity in the active pharmaceutical ingredient that is classified as a potential human carcinogen. Long-term exposure to this substance could potentially increase the risk of developing cancer.

What You Should Do

  1. Identify if you have the affected medication by checking the NDC number and batch/lot codes on your prescription bottle. Affected products include Valsartan Tablets (NDC 13668-068-90, 13668-069-90, 13668-070-90), Amlodipine and Valsartan (NDC 13668-204-30, 13668-205-30, 13668-206-30, 13668-207-30), and Amlodipine/Valsartan/HCTZ combinations (NDC 13668-325-30, 13668-326-30, 13668-327-30, 13668-328-30, 13668-329-30).
  2. Check for specific affected batches such as BV46C007, BV47C005, BV48D001, BV77D013, BV84D010, BV65D002, BV53D004, BBX2D025, BBY1E001, BBY2E001, BBX9D004, and BBY4D004 (refer to the full product list for all associated batch codes).
  3. Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the recalled medication. Stopping blood pressure medicine suddenly can cause serious health problems.
  4. Return any unused portions of the affected medication to your pharmacy for a refund and to ensure proper disposal.
  5. Contact Torrent Pharma Inc. if you have additional questions regarding the return process or if you need further clarification on the affected lot numbers.
  6. For further information or to report any adverse reactions, 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

Pharmaceutical product return for refund

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, 80mg (90 tablets per bottle)
Model:
NDC: 13668-068-90
Lot Numbers:
BV46C007
BV46C008
BV46C009
BV46C010
BV46C011
BV46C012
BV46C003
BV46C006
Product: Valsartan Tablets USP, 160mg (90 tablets per bottle)
Model:
NDC: 13668-069-90
Lot Numbers:
BV47C005
BV47C006
BV47D001
BV47C003
BV47C004
Product: Valsartan Tablets USP, 320mg (90 tablets per bottle)
Model:
NDC: 13668-070-90
Lot Numbers:
BV48D001
BV48D002
Product: Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg (30 tablets per bottle)
Model:
NDC: 13668-204-30
Lot Numbers:
BV77D013
BV77C011
BV77D001
BV77D002
BV77D003
BV77D004
BV77D005
BV77D006
BV77D007
BV77D008
BV77D009
BV77D010
BV77D011
BV77D012
BV77C009
BV77C010
Product: Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg (30 tablets per bottle)
Model:
NDC: 13668-205-30
Lot Numbers:
BV84D010
BV84E001
BV84C011
BV84D001
BV84D002
BV84D005
BV84D006
BV84D007
BV84D008
BV84D009
BV84C006
BV84C007
BV84C008
BV84C009
Product: Amlodipine and Valsartan Tablets, USP, 10 mg/160mg (30 tablets per bottle)
Model:
NDC: 13668-206-30
Lot Numbers:
BV65D002
BV65C002
BV65C003
BV65C004
BV65D001
Product: Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg (30 tablets per bottle)
Model:
NDC: 13668-207-30
Lot Numbers:
BV53D004
BV53C006
BV53D001
BV53D002
BV53D003
BV53C004
BV53C005
Product: Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg (30 tablets per bottle)
Model:
NDC: 13668-325-30
Lot Numbers:
BBX2D025
BBX2D026
BBX2E001
BBX2E002
BBX2E003
BBX2E004
BBX2E005
BBX2D003
BBX2D004
BBX2D005
BBX2D006
BBX2D007
BBX2D008
BBX2D015
BBX2D016
BBX2D017
BBX2D018
BBX2D019
BBX2D020
BBX2D021
BBX2D022
BBX2D023
BBX2D024
BBX2D001
BBX2D002
BBX2D009
BBX2D010
BBX2D011
BBX2D012
BBX2D013
BBX2D014
BBX2C007
Product: Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg (30 tablets per bottle)
Model:
NDC: 13668-326-30
Lot Numbers:
BBY1E001
BBY1E003
BBY1C002
BBY1E002
BBY1D001
Product: Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg (30 tablets per bottle)
Model:
NDC: 13668-327-30
Lot Numbers:
BBY2E001
BBY2D001
BBY2D002
Product: Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg (30 tablets per bottle)
Model:
NDC: 13668-328-30
Lot Numbers:
BBX9D004
BBX9E001
BBX9D001
BBX9D002
BBX9D003
Product: Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg (30 tablets per bottle)
Model:
NDC: 13668-329-30
Lot Numbers:
BBY4D004
BBY4E001
BBY4D001
BBY4D002
BBY4D003

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80847
Status: Active
Manufacturer: Torrent Pharma Inc.
Sold By: Pharmacies; Healthcare providers
Manufactured In: India
Units Affected: 12 products (24468 bottles; 14016 bottles; ALL; 89616 bottles; 66864 bottles; 46272 bottles; 78144 bottles; 169,200 bottles; 50,784 bottles; 22704 bottles; 34320 bottles; 37704 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.