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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 Capsules Recalled for Quality Control Deviations

Agency Publication Date: May 20, 2022
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Summary

Direct Rx is recalling 16 bottles of Zonisamide (zonisamide) Capsules USP (100 mg), a medication used to treat seizures. This recall was initiated due to gaps and deviations in the Quality Control microbiology laboratory systems at the manufacturing site. No illnesses or injuries have been reported to date in connection with this specific batch.

Risk

Gaps in quality control systems mean the product may not meet all safety and purity standards, potentially affecting the medication's effectiveness or safety. While no injuries are reported, deviations in a microbiology lab can lead to concerns regarding potential contamination.

What You Should Do

  1. This recall affects 90-count bottles of Zonisamide Capsules USP, 100 mg, with NDC 61919-775-90 and lot number 23JY2124 (Expiration date: 6/30/23).
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Direct Rx for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

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 Capsules USP, 100 mg (90-count bottle)
Variants: 100 mg, 90-count bottle
Lot Numbers:
23JY2124 (Exp. 6/30/23)
NDC:
61919-775-90

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534; Manufactured for: Glenmark Pharmaceuticals Inc., USA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90215
Status: Resolved
Manufacturer: Direct Rx
Sold By: Direct Rx
Manufactured In: United States
Units Affected: 16 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.