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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/Topical Products

Novartis Pharmaceuticals Corp.: Defective container: Possibility of tubes leaking.

Agency Publication Date: September 17, 2005
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Summary

Novartis Pharmaceuticals is recalling 13,056 tubes of Genteal Gel Severe Lubricant Eye Gel (hypromellose 0.3%) because the product containers are defective and may leak. This lubricant eye gel is used to relieve dryness of the eye and was sold nationwide at major retailers including Rite-Aid, Walmart, Target, and K-Mart. Consumers who have this product should check the identifying NDC number on the packaging and consult with a medical professional regarding use.

Risk

The defective tubes may leak, which can lead to product loss and potential contamination of the eye gel, posing a risk to users who apply the medication to their eyes.

What You Should Do

  1. Check your product packaging for the name Genteal Gel Severe Lubricant Eye Gel and NDC 58768-790-36 to see if your eye gel is affected.
  2. Inspect the tube for any signs of leaking or container damage.
  3. Contact your healthcare provider or pharmacist for guidance regarding the use of this product or if you have experienced any irritation or problems.
  4. Return any unused product to the pharmacy or retail store where it was purchased for a refund.
  5. Contact Novartis Pharmaceuticals Corp. at 1 Health Plz, East Hanover, New Jersey for further instructions.
  6. For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

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

How to: Return the affected product to the place of purchase for a refund and consult a medical professional.

Affected Products

Product: Genteal Gel Severe Lubricant Eye Gel (0.3% Hypromellose)
Model:
NDC 58768-790-36

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 32442
Status: Active
Manufacturer: Novartis Pharmaceuticals Corp.
Manufactured In: United States
Units Affected: 13056 tubes

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.