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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Hetero Labs, Ltd. - Unit III: Fenofibrate Tablets Recalled for Co-mingling with Valacyclovir Tablets

Agency Publication Date: September 25, 2018
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Summary

Hetero Labs is recalling 5,424 bottles of Fenofibrate (145 mg), a medication used to lower cholesterol and triglycerides. The recall was initiated because a different medication, a Valacyclovir tablet (500 mg) used to treat viral infections, was found inside a bottle of Fenofibrate. These affected bottles were manufactured for Camber Pharmaceuticals and distributed to Indiana and Louisiana. Consumers should check their prescription bottles immediately to ensure they contain the correct medication.

Risk

Taking an incorrect medication like Valacyclovir instead of Fenofibrate could lead to ineffective treatment of your condition or unintended side effects from the foreign drug. This co-mingling occurred during the packaging process, posing a risk that patients may accidentally ingest the wrong medicine.

What You Should Do

  1. Check your medication bottle for the product name 'Fenofibrate Tablets, USP 145 mg' in 90-count bottles with NDC 31722-596-90.
  2. Identify if your bottle is part of the recall by looking for Lot number E181370 with an expiration date of 5/2020.
  3. Carefully inspect the tablets inside the bottle; this recall was triggered because a 500 mg Valacyclovir tablet was found mixed in with the Fenofibrate tablets.
  4. If you identify a foreign tablet or have one of the affected lot numbers, contact your healthcare provider or pharmacist immediately for guidance and to obtain a safe replacement.
  5. Return any unused or affected product to your pharmacy for a refund and contact Hetero Labs or Camber Pharmaceuticals for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Drug recall remedy for co-mingled tablets

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

Affected Products

Product: Fenofibrate Tablets, USP (145 mg), 90-count bottles
Model:
NDC 31722-596-90
D-1211-2018
Lot Numbers:
E181370 (Exp. 5/2020)
Date Ranges: Exp. 5/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81017
Status: Resolved
Manufacturer: Hetero Labs, Ltd. - Unit III
Sold By: Camber Pharmaceuticals, Inc.
Manufactured In: India
Units Affected: 5,424 bottles
Distributed To: Indiana, Louisiana

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.