FDA DrugsClass II
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alc...
Published: May 6, 2026Recall ID: D-0492-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Fort Worth |
| State | TX |
| Openfda › Upc | 0300658064011 |
| Openfda › Unii | RN3152OP35 |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 310932 |
| Openfda › Rxcui › 2 | 793204 |
| Openfda › Spl id | 750c99c5-ade3-4759-870b-cb59248e9fa0 |
| Openfda › Brand name | GENTEAL TEARS |
| Openfda › Spl set id | a57854fc-f3a2-4fbb-b718-cd06f87a721e |
| Openfda › Package ndc | 0065-8064-01 |
| Openfda › Product ndc | 0065-8064 |
| Openfda › Generic name | HYPROMELLOSE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | HYPROMELLOSE 2910 (4000 MPA.S) |
| Openfda › Manufacturer name | Alcon Laboratories, Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98815 |
| Address 1 | 6201 South Fwy |
| 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. |
| Postal code | 76134-2099 |
| Report date | 20260506 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260421 |
| Initial firm notification | Letter |
| Center classification date | 20260424 |
Overview
- Recalling FirmAlcon Research LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States