Class II · ModerateActive recall
Systane
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot#: 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.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAlcon Laboratories, Inc.
| Brand name | SYSTANE |
| Generic name | HYPROMELLOSE |
| Active ingredient(s) | HYPROMELLOSE 2910 (4000 MPA.S) |
| Distributed by / for | Alcon Research LLC |
| NDC | 0065-0474-01 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Alcon Research LLC |
| Distribution | Nationwide within the United States |
| Recall initiated | 2026-04-21 |
| Report date | 2026-05-06 |
| Recall completed | — |
| Recall number | D-0491-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Fort Worth TX United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.