Systane recalled over sterility concerns

Recall date

April 21, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Alcon Research LLC recalls Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort…

Recall number

D-0491-2026

FDA classification

Class II

Brand / firm

Alcon Research LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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