Alcon Research LLC: Drug Recall

Recall #D-0200-2025 · 12/18/2024

Class I: Dangerous

Recall Details

Recall Number: D-0200-2025
Classification: Class I
Product Type: Drug
Recalling Firm: Alcon Research LLC
Status: Ongoing
Date Initiated: 12/18/2024
Location: Fort Worth, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 55,960 25-count boxes

Reason for Recall

Non-Sterility

Product Description

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

Distribution Pattern

US Nationwide.

Other Recalls by Alcon Research LLC

Class I: Dangerous 11/24/2025

Ophthalmic procedure packs may have incomplete seals affecting sterility.
Class II: Risk 09/30/2025

Potential for a weak seal in some units resulting in compromise in sterility.
Class II: Risk 09/15/2025

XXX
Class II: Risk 08/05/2025

Due to incomplete seals in the pouch which provide the sterile barrier.
Class II: Risk 08/05/2025

Due to incomplete seals in the pouch which provide the sterile barrier.

View all recalls by Alcon Research LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.