CLASS III Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile recalled
AuroMedics Pharma is recalling Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, distributed nationwide in the US. The recall was initiated on 2 Dec 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0789-2020
- FDA event ID
- 84498
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Moxifloxacin
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 17 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 17 Jan 2020 | Classified by FDA | +46 days |
| 22 Jan 2020 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Which lots are affected?
Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
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Other Moxifloxacin recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Moxifloxacin 0.8 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 4 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 5mg/ml in a Single- Dose Vial recalled by Denver Solutions | Denver Solutions | Particulate Matter | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution, Solution recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution 400 mcg/ (100 mcg/ syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |