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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Vigabatrin for Oral Solution Recalled Due to Leaking Pouches

Agency Publication Date: January 8, 2024
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Summary

InvaGen Pharmaceuticals, Inc. and Cipla USA, Inc. are recalling 1,240 boxes of Vigabatrin for Oral Solution (500 mg per packet) because the individual medication pouches may be defective and leak powder. If the medicine leaks, patients may receive a lower dose than prescribed, which can lead to serious health complications like worsening seizures. No incidents or injuries have been reported to date.

Risk

A leaking pouch can lead to an underdose of medication, potentially causing a loss of seizure control or leading to a medical emergency. If you notice powder leaking from the packaging, the dosage may be incorrect.

What You Should Do

  1. The recalled products are Vigabatrin for Oral Solution (500 mg per packet), sold in boxes containing 50 packets under NDC 69097-964-53.
  2. Check your medication packaging for lot number NB301030 with an expiration date of 03/31/2025.
  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 InvaGen Pharmaceuticals, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

💰Option 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
🗑️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: Vigabatrin for Oral Solution (500 mg per packet)
Variants: 500 mg, 50 packets per box, Powder
Lot Numbers:
NB301030 (Exp 03/31/2025)
NDC:
69097-964-53

Recall #: D-0220-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93422
Status: Resolved
Manufacturer: InvaGen Pharmaceuticals, Inc.
Sold By: pharmacies; hospitals
Manufactured In: United States
Units Affected: 1240 boxes
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 · FDA Press Release (1) · FDA Press Release (2) · 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.