Ofloxacin Ophthalmic Solution — Class II drug recall D-0146-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0146-2023 |
|---|---|
| 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 | 65,006 bottles |
| Reason classes | cgmp |
| NDC | 13985-0602-05 |
| Lot numbers | 11B26A, 1H02A |
| Expiration dates | 2023-01-31, 2023-07-31 |
Product
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
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-0146-2023. 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.