Artificial Tears Ointment — Class II drug recall D-0786-2021
Terminated recall by Akorn, Inc., reported 2021-09-08, distributed nationwide. Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing.
| Recall number | D-0786-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2021-08-02 |
| Classified | 2021-08-31 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2022-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 142,188 tubes |
| Reason classes | microbial contamination, sterility, specification failure |
| Pathogens | bacillus cereus |
| NDC | 17478-0062-35 |
| Lot numbers | 9G01A, 9H32A, 9K82A, 9K82B |
| Expiration dates | 2022-06, 2022-07, 2022-09 |
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
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
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-0786-2021. 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.