Home / Recalls / Alcon Research LLC / D-0492-2026

D-0492-2026 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

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.

Other recalls by Alcon Research LLC

  • D-0491-2026 Class II — Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran (April 21, 2026)
  • Z-0939-2026 Class I — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (November 24, 2025)
  • Z-0326-2026 Class II — Alcon PRECISION1 One-Day Contact Lenses, -2.25D. (September 30, 2025)
  • Z-0581-2026 Class II — CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ (September 15, 2025)
  • Z-0304-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0308-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0305-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0306-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0307-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-2108-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System (April 28, 2025)