TheraTears Extra — Class II drug recall D-0717-2022
Terminated recall by Akorn, Inc., reported 2022-03-30, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0717-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2021-09-08 |
| Classified | 2022-03-24 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2023-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 62,331 boxes |
| Reason classes | sterility |
| NDC | 58790-0010, 58790-0010-30 |
| Lot numbers | 913012, 913013, 913014 |
| Expiration dates | 2023-01-31 |
Product
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
Reason for recall
Lack of Assurance of Sterility
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-0717-2022. 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.