CLASS II Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, Sterile recalled
Aurobindo Pharma USA is recalling Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, Sterile, distributed nationwide in the US. The recall was initiated on 14 Jan 2022 and the FDA has classified it as Class II.
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-0560-2022
- FDA event ID
- 89423
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2022
- FDA classified
- 14 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 14 Jan 2022 | Recall initiated by company | |
| 14 Feb 2022 | Classified by FDA | +31 days |
| 23 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot#: CMF210001, CMF210003, CMF210004, Exp 6/2023
Where was it sold?
USA Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 1 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
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 |