Moxifloxacin Ophthalmic Solution USP — Class III drug recall D-0789-2020
Terminated recall by AuroMedics Pharma LLC, reported 2020-01-22, distributed nationwide. Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
| Recall number | D-0789-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2019-12-02 |
| Classified | 2020-01-17 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2022-11-22 |
| Distributed | Nationwide (US) |
| Quantity | 100,080 bottles |
| NDC | 65862-0840, 65862-0840-03 |
| Lot numbers | CMF190008, CMF190009, CMF190025, CMF190026 |
| Expiration dates | 2021-04, 2021-06 |
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
Reason for recall
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
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-0789-2020. 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.