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CLASS II · ModerateFDA

Alcon Research LLC recalls GenTeal Tears

📅 Apr 21, 2026 · 📍 Nationwide
Recalling company
Alcon Research LLC
Product
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
Reason
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 21, 2026
Reported
May 6, 2026
Distribution
Nationwide within the United States
Status
Ongoing
Lot / codes
Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
Company location
Fort Worth, TX
Recall type
Voluntary: Firm initiated
Recall number
D-0492-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0492-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.