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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

Hetero Labs Limited Unit V: Valsartan Tablets Recalled Due to Carcinogen Impurity

Agency Publication Date: August 23, 2018
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Summary

Approximately 1,594,092 units of Camber Pharmaceuticals Valsartan (valsartan) tablets are being recalled because a carcinogen impurity was detected in the active ingredient used to manufacture the drug. This recall affects various dosages including 40 mg, 80 mg, 160 mg, and 320 mg strengths sold in 30-count and 90-count bottles. No specific injuries have been reported, but patients are advised to contact their doctor or pharmacist immediately as suddenly stopping blood pressure medication can pose health risks. These products were distributed nationwide to pharmacies and healthcare providers.

Risk

The medication contains an impurity classified as a probable human carcinogen, which may increase the risk of cancer with long-term exposure. Because this drug treats high blood pressure and heart failure, the risk of harm to the patient from suddenly stopping the medication may be greater than the risk posed by the impurity.

What You Should Do

  1. Identify your medication by checking the label for the brand name Camber Pharmaceuticals, Inc. and the specific NDC and UPC codes listed below.
  2. Check the expiration dates on your prescription bottle; this recall affects all lots with expiration dates ranging from 7/2018 to 6/2020.
  3. Do NOT stop taking your medication without first talking to your doctor or pharmacist, as stopping valsartan abruptly can cause serious health complications.
  4. Contact your healthcare provider or pharmacist for a replacement prescription or to discuss alternative treatment options.
  5. Once you have a replacement, return any unused portion of the recalled medication to your pharmacy for a refund and further instructions.
  6. 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

๐Ÿ’ฐFull Refund

Pharmaceutical refund and medical consultation

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

Affected Products

Product: Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg (30 Tablets)
Model:
NDC 31722-745-30
Recall #: D-1113-2018
UPC Codes:
331722745307
Lot Numbers:
All Lots
Date Ranges: 7/2018 to 6/2020
Product: Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg (90 count bottles)
Model:
NDC 31722-746-90
Recall #: D-1114-2018
UPC Codes:
331722746908
Lot Numbers:
All Lots
Date Ranges: 7/2018 to 6/2020
Product: Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg (90 tablets)
Model:
NDC 31722-747-90
Recall #: D-1115-2018
UPC Codes:
331722747905
Lot Numbers:
All Lots
Date Ranges: 7/2018 to 6/2020
Product: Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg (90 tablets)
Model:
NDC 31722-748-90
Recall #: D-1116-2018
UPC Codes:
331722748902
Lot Numbers:
All Lots
Date Ranges: 7/2018 to 6/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80773
Status: Resolved
Manufacturer: Hetero Labs Limited Unit V
Sold By: Pharmacies; Healthcare Providers
Manufactured In: India
Units Affected: 4 products (316,380 bottles; 394,896 bottles; 441,408 bottles; 441,408 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.

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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 ยท 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.