Artificial Tears OINTMENT — Class II drug recall D-0133-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0133-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Gurnee, IL, United States |
| Recall initiated | 2022-10-13 |
| Classified | 2023-01-13 |
| Reported by FDA | 2023-01-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,164,171 tubes |
| Reason classes | cgmp |
| NDC | 17478-0062-35 |
| Lot numbers | 0A08B, 0B63A, 0C72A, 0D14A, 0D19A, 0F54A, 0G09B, 0G80B, 0G97A, 0J78A, 0K23A, 0L64A, 1B29A, 1C53A, 1C59A, 1C72A, 1C78A, 1D87A, 1D89A, 1G59A, 1G59B, 1H86A, 1J57A, 1K60A, 1K75A, 1L12A, 1M22A |
| Expiration dates | 2022-12-31, 2023-01-31, 2023-02-28, 2023-03-31, 2023-05-31, 2023-06-30, 2023-08-31, 2023-09-30, 2023-10-31, 2024-01-31, 2024-02-29, 2024-03-31, 2024-06-30, 2024-07-31, 2024-08-31, 2024-09-30, 2024-10-31, 2024-11-30 |
Product
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
Reason for recall
CGMP Deviations:
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-0133-2023. 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.