Home / Recalls / Alcon Research LLC / D-0200-2025

D-0200-2025 Class I Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

FDA drug recall D-0200-2025 was initiated by Alcon Research LLC on December 18, 2024 and is designated Class I. Reason for recall: Non-Sterility The recall status is ongoing. Affected quantity: 55,960 25-count boxes.

Recall Details

Product Type: Drugs
Report Date: January 22, 2025
Initiation Date: December 18, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 55,960 25-count boxes

Product Description

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

Reason for Recall

Non-Sterility

Distribution Pattern

US Nationwide.

Code Information

Lot 10101; Exp.09/30/2025

Other recalls by Alcon Research LLC

D-0492-2026 Class II — GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alc (April 21, 2026)
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-0307-2026 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-0304-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)