D-0492-2026 Class II Ongoing
FDA drug recall D-0492-2026 was initiated by Alcon Research LLC on April 21, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- May 6, 2026
- Initiation Date
- April 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 for Recall
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Distribution Pattern
Nationwide within the United States
Code Information
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.