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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

Prinston Pharmaceutical Inc: Valsartan and HCTZ Tablets Recalled Due to Carcinogen Impurity

Agency Publication Date: July 20, 2018
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Summary

Prinston Pharmaceutical Inc. has recalled several versions of Solco Healthcare US Valsartan and Valsartan/Hydrochlorothiazide (HCTZ) tablets, used to treat high blood pressure and heart failure. The recall was initiated because a cancer-causing impurity called N-nitrosodimethylamine (NDMA) was detected in the active ingredient used to make the tablets. This recall affects all lots of these specific medications that have not yet expired and were distributed nationwide across the United States.

Risk

The tablets contain a carcinogen impurity that may increase the risk of cancer with long-term exposure. While no immediate injuries have been reported, patients are advised not to stop taking their medication abruptly without a replacement, as untreated high blood pressure can lead to serious cardiovascular events.

What You Should Do

  1. Check your prescription bottle label to see if your medication is 'Solco Healthcare US' brand Valsartan or Valsartan/HCTZ with NDC codes 43547-367-03, 43547-368-09, 43547-369-09, 43547-370-09, 43547-311-09, 43547-312-09, 43547-313-09, 43547-314-09, or 43547-315-09.
  2. Identify if your product is part of the recall by confirming the manufacturer is Zhejiang Huahai Pharmaceutical Co., Ltd.; the recall includes all lots currently within their expiration dates.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement or alternative medication before you stop taking the recalled drug.
  4. Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund and further instructions.
  5. Contact Prinston Pharmaceutical Inc. or Solco Healthcare US directly if you have questions regarding the return process.
  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

Return to pharmacy for refund and replacement guidance

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

Affected Products

Product: Solco Healthcare US Valsartan, USP, 40 MG Tablets (30-count bottle)
Model:
NDC 43547-367-03
D-0968-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan, USP, 80 MG Tablets (90-count bottle)
Model:
NDC 43547-368-09
D-0969-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan, USP, 160 MG Tablets (90-count bottle)
Model:
NDC 43547-369-09
D-0970-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan, USP, 320 MG Tablets (90-count bottle)
Model:
NDC 43547-370-09
D-0971-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets (90-count bottle)
Model:
NDC 43547-311-09
D-0972-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets (90-count bottle)
Model:
NDC 43547-312-09
D-0973-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets (90-count bottle)
Model:
NDC 43547-313-09
D-0974-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets (90-count bottle)
Model:
NDC 43547-314-09
D-0975-2018
Lot Numbers:
All lots within expiry
Product: Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets (90-count bottle)
Model:
NDC 43547-315-09
D-0976-2018
Lot Numbers:
All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80525
Status: Active
Manufacturer: Prinston Pharmaceutical Inc
Sold By: Pharmacies
Manufactured In: China, United States
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 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.