GenTeal Tears — Class II drug recall D-0492-2026
Ongoing recall by Alcon Research LLC, reported 2026-05-06, distributed nationwide. Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality
| Recall number | D-0492-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2026-04-21 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 00065-8064, 00065-8064-01 |
| Lot numbers | 1U30, 1U48, 1W47, 1W49, 1X14, 4V15, 7V61, 9T20, 9T50, 9T59 |
| Expiration dates | 2026-04-30, 2026-08-31, 2026-12-31, 2027-03-31 |
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 for recall
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0492-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.