Warning
Alcon Research LLC Recalls Systane
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0491-2026Drug / Pharmaceutical
Alcon Research LLC Recalls Systane
Alcon Research LLC · Class II — Moderate Risk
Product Description
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 for Recall
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Alcon Research LLC has recalled a pharmaceutical product that the FDA classified as Class II. The recall was initiated on April 21, 2026. Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.