Clear Eyes — Class II drug recall D-0469-2023
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2023-03-22, distributed nationwide. Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified
| Recall number | D-0469-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2023-02-23 |
| Classified | 2023-03-20 |
| Reported by FDA | 2023-03-22 |
| Terminated | 2023-11-28 |
| Distributed | Nationwide (US) |
| Quantity | 715,632 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00678112000708 |
| NDC | 67172-0504-01 |
| Lot numbers | 114349, 114371, 117396, 120128, 123781 |
| Expiration dates | 2023-05, 2023-06, 2023-09, 2023-11, 2024-02 |
Product
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01.
Reason for recall
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
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-0469-2023. 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.