Class II · ModerateActive recall
Genteal Tears
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
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 | GENTEAL TEARS |
| Generic name | HYPROMELLOSE |
| Active ingredient(s) | HYPROMELLOSE 2910 (4000 MPA.S) |
| Distributed by / for | Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA |
| NDC | 0065-8064-01 |
Show the full FDA record
| Full product label | GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01. |
| 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-0492-2026 |
| 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.