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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

Direct Rx Zonisamide 100 mg Capsules Recalled for Quality Control Deviations

Agency Publication Date: September 23, 2021
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Summary

Direct Rx has recalled two bottles of Zonisamide (100 mg capsules) due to quality control deviations in their microbiology laboratory. Zonisamide is a medication used to treat seizures in adults with epilepsy. This recall involves 30-count bottles distributed exclusively in Florida. No incidents or injuries have been reported in connection with this recall.

Risk

Deficiencies in the laboratory's quality control systems mean the manufacturer cannot guarantee the product's safety or sterility. While no specific illnesses have been reported, these gaps could potentially lead to products that do not meet required quality standards.

What You Should Do

  1. The recalled products are 30-count bottles of Zonisamide 100 mg Capsules (NDC 61919-0775-30) labeled as packaged and distributed by Direct Rx.
  2. Check your medication bottle for lot number 17JU2118 with an expiration date of 5/31/23.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Zonisamide 100 mg Capsules (30-count bottle)
Variants: 100 mg, Capsule
Lot Numbers:
17JU2118 (Exp. 5/31/23)
NDC:
61919-0775-30

Packaged and Distributed By: Direct Rx Dawsonville, GA. Manufactured for Glenmark Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88749
Status: Resolved
Manufacturer: Direct Rx
Sold By: Direct Rx
Manufactured In: United States
Units Affected: 2 bottles
Distributed To: Florida

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.