Recall: D-0491-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-21Initiated

OngoingStatus

Alcon Research LLCFirm

Product

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

Reason

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.