FDA DrugsClass II
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, S...
Published: May 20, 2026Recall ID: D-0525-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Product Description & Identification
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
Additional Source Details
| Field | Value |
|---|---|
| City | Glendora |
| State | CA |
| Openfda › Nui › 1 | N0000185370 |
| Openfda › Nui › 2 | N0000175629 |
| Openfda › Nui › 3 | N0000184306 |
| Openfda › Nui › 4 | N0000185001 |
| Openfda › Nui › 5 | M0000728 |
| Openfda › Nui › 6 | M0009417 |
| Openfda › Unii | PDC6A3C0OX |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 310541 |
| Openfda › Rxcui › 2 | 1598052 |
| Openfda › Spl id | 58c4a89f-c811-462c-a212-fa35c2e46864 |
| Openfda › Brand name | OASIS TEARS PF |
| Openfda › Spl set id | 640f95f4-c2e8-48ad-ad40-f76bbaddb0dc |
| Openfda › Package ndc | 42126-6400-1 |
| Openfda › Product ndc | 42126-6400 |
| Openfda › Generic name | GLYCERIN |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs › 1 | Allergens [CS] |
| Openfda › Pharm class cs › 2 | Glycerol [CS] |
| Openfda › Pharm class pe › 1 | Increased Histamine Release [PE] |
| Openfda › Pharm class pe › 2 | Cell-mediated Immunity [PE] |
| Openfda › Pharm class pe › 3 | Increased IgG Production [PE] |
| Openfda › Substance name | GLYCERIN |
| Openfda › Pharm class epc | Non-Standardized Chemical Allergen [EPC] |
| Openfda › Manufacturer name | OASIS Medical, Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98897 |
| Address 1 | 510 S Vermont Ave # 528 |
| Code info | Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26. |
| Postal code | 91741-6205 |
| Report date | 20260520 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Letter |
| Center classification date | 20260508 |
Overview
- Recalling FirmOasis Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States