FDA Drugs recall ·
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz)… recall
- Recall number
- D-0491-2026
- Date
- (initiated April 21, 2026)
- Company / brand
- Alcon Research LLC
6201 South Fwy, Fort Worth, TX, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0491-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.