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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 Tablets Recalled for Thicker and Heavier Tablets

Agency Publication Date: January 8, 2018
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Summary

Prinston Pharmaceutical Inc. has recalled approximately 21,987 bottles of Valsartan (160 mg), a prescription blood pressure medication. This recall was initiated after a customer reported finding tablets that were thicker and heavier than they should be within the bottle. Consumers should be aware that these tablets may contain an incorrect dosage or fail to meet quality standards. If you have this medication, you should contact your doctor or pharmacist to discuss an alternative treatment before you stop taking your prescribed dose.

Risk

The presence of thicker and heavier tablets indicates a manufacturing failure that can result in patients receiving an inconsistent or incorrect dose of their blood pressure medication. Taking an incorrect dosage could lead to ineffective management of blood pressure or potential adverse health effects from receiving more medication than intended.

What You Should Do

  1. Check your medication bottle for Valsartan Tablets, USP, 160 mg in 90-count bottles with NDC 43547-369-09.
  2. Verify if your bottle matches Lot Number 343B17025 with an expiration date of 03/31/19.
  3. Inspect the tablets; if they appear unusually thick or heavy compared to your previous refills, they may be part of the affected batch.
  4. Contact your healthcare provider or pharmacist immediately for guidance on whether to continue your current supply or to obtain a replacement.
  5. Return any unused or affected product to your pharmacy for a refund and to ensure the defective tablets are properly handled.
  6. Contact the manufacturer, Prinston Pharmaceutical Inc., at their distributor Solco Healthcare US, LLC in Cranbury, NJ for further instructions.
  7. Call the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product to pharmacy.

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, 160 mg (90-count bottle)
Model:
NDC 43547-369-09
Recall #: D-0209-2018
Lot Numbers:
343B17025 (Exp 03/31/19)
Date Ranges: Expiration date 03/31/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78651
Status: Resolved
Manufacturer: Prinston Pharmaceutical Inc
Sold By: Solco Healthcare US, LLC; pharmacies
Manufactured In: China, United States
Units Affected: 21,987 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 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.