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FDA · Drugs ·

Systane recall

Alcon Research LLC recalled Systane on May 6, 2026 because of lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. It was sold nationwide.

Why it was recalled

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

What's 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

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Alcon Research LLC, Fort Worth, TX
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the United States
Status
Ongoing
Recall number
D-0491-2026
Source
U.S. Food and Drug Administration

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