FDA Recall D-0200-2025

Alcon Research LLC · Fort Worth, TX

Class I — life-threatening Ongoing 512 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot 10101; Exp.09/30/2025

Quantity: 55,960 25-count boxes

Reason for recall

Non-Sterility

Recall record

Recall number: D-0200-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2024-12-18
Classified by FDA Center: 2025-01-13
FDA published: 2025-01-22
Recalling firm: Alcon Research LLC
Firm location: Fort Worth, TX

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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