FDA Drug recall D-0492-2026
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0… by Alcon Research, citing lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0492-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
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.
Reason
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Identifiers
| ndc | 0065-8064-01 |
|---|---|
| code_info | Lot #: 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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2026%22
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