FDAHealthApril 21, 2026
Alcon Research LLC — 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.
⚠️ Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 21, 2026
Nationwide within the United States
What's affected?
- 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.
- Brand
- GENTEAL TEARS
- UPC
- 0300658064011
- Lot code
- 9T20
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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