Artificial Tears Solution — Class II drug recall D-0134-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0134-2023 |
|---|---|
| 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 | 967,075 bottles |
| Reason classes | cgmp |
| NDC | 17478-0060-12 |
| Lot numbers | 0L44A, 0L51A, 0L52A, 0L75A, 0L77A, 0M01A, 0M02A, 1C81A, 1D02A, 1D03A, 1E08A, 1E10A, 1E23A, 1E25A, 1E26A, 1E27A, 1E33A, 1F46A, 1G49A, 1G50A, 1G67A, 1H04A, 1H05A, 1H07A, 1H13A, 1H15A, 1H74A, 1H76A, 1H95A, 1J20A, 1J44A |
| Expiration dates | 2022-10-31, 2022-11-30, 2023-02-28, 2023-03-31, 2023-04-30, 2023-05-31, 2023-06-30, 2023-07-31, 2023-08-31 |
Product
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
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-0134-2023. 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.