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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/Topical Products

Systane and GenTeal Tears Eye Gels Recalled for Sterility Concerns

Agency Publication Date: April 24, 2026
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Summary

Alcon Research LLC is voluntarily recalling several lots of Systane Lubricant Eye Gel (Night Gel) and GenTeal Tears Lubricant Eye Gel due to concerns regarding the sterility of the products. The recall was initiated following FDA inspection observations that may impact product quality, although no incidents or injuries have been reported to date. These products were sold in pharmacies and drugstores nationwide in 10g (0.35 oz or 0.34 fl oz) tubes.

Risk

If an eye gel is not sterile, it may contain harmful microorganisms that can cause serious eye infections when applied directly to the surface of the eye. Because these products are intended for ophthalmic use, any compromise in sterility poses a significant health risk to consumers.

What You Should Do

  1. Check your Systane or GenTeal Tears packaging for the following affected NDC numbers: 0065-0474-01 or 0065-8064-01.
  2. Verify the lot numbers and expiration dates on the tube or carton. See the Affected Products section below for the full list of affected codes.
  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 (1-888-SAFEFDA) for additional questions.

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: Systane, Lubricant Eye Gel, Night Gel, Sterile (10g / 0.35 oz)
Lot Numbers:
9T21 (Exp Date: 4/30/2026)
1U63 (Exp Date: 5/31/2026)
2U47 (Exp Date: 5/31/2026)
6V00 (Exp Date: 1/31/2027)
6V12 (Exp Date: 1/31/2027)
8V54 (Exp Date: 1/31/2027)
9V55 (Exp Date: 2/28/2027)
8V58 (Exp Date: 2/28/2027)
9V39 (Exp Date: 2/28/2027)
9V97 (Exp Date: 2/28/2027)
1W39 (Exp Date: 3/31/2027)
1W40 (Exp Date: 3/31/2027)
1X76 (Exp Date: 4/30/2027)
NDC:
0065-0474-01

Processed in France for Alcon Laboratories, Inc.

Product: GenTeal Tears, Lubricant Eye Gel, Sterile (10g / 0.34 Fl oz)
Lot Numbers:
9T20 (Exp Date: 4/30/2026)
9T50 (Exp Date: 4/30/2026)
9T59 (Exp Date: 4/30/2026)
1U30 (Exp Date: 4/30/2026)
1U48 (Exp Date: 4/30/2026)
4V15 (Exp Date: 8/31/2026)
7V61 (Exp Date: 12/31/2026)
1W47 (Exp Date: 3/31/2027)
1W49 (Exp Date: 3/31/2027)
1X14 (Exp Date: 3/31/2027)
NDC:
0065-8064-01

Distributed by Alcon Laboratories, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98815
Status: Active
Manufacturer: Alcon Research LLC
Sold By: Pharmacies; Drugstores
Manufactured In: France, United States
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.