FDAFDA · Food and drugs·Recall number D-0492-2026
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.
Published May 6, 2026 · Recall initiated: April 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GENTEAL TEARS
- Manufacturer
- Alcon Research LLC
- Distributor
- Nationwide within the United States
- UPC
- 0300658064011
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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