Ketorolac Tromethamine Ophthalmic Solution — Class II drug recall D-0141-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0141-2023 |
|---|---|
| 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 | 314,543 |
| Reason classes | cgmp |
| NDC | 17478-0209-10, 17478-0209-11, 17478-0209-19 |
| Lot numbers | 0L40A, 1A09A, 1B38A, 1E12A, 1E32A, 1F41A, 1F45A, 1G68A, 1G73A, 1H01A, 1H08A, 1H12A, 1H99A, 1K84A |
| Expiration dates | 2022-10-31, 2022-12-31, 2023-01-31, 2023-04-30, 2023-05-31, 2023-06-30, 2023-07-31, 2023-09-30 |
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
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-0141-2023. 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.