Moxifloxacin Ophthalmic Solution — Class II drug recall D-0560-2022
Terminated recall by Aurobindo Pharma USA Inc., reported 2022-02-23, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0560-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2022-01-14 |
| Classified | 2022-02-14 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2024-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 115,776 bottles |
| Reason classes | specification failure |
| NDC | 65862-0840, 65862-0840-03 |
| Lot numbers | CMF210001, CMF210003, CMF210004 |
| Expiration dates | 2023-06 |
Product
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
Reason for recall
Failed Impurities/Degradation Specifications
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-0560-2022. 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.