CLASS III Drug recall · Reported 8 Aug 2018 · FDA Enforcement Report
Moxifloxacin Ophthalmic Solution recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution USP, 0.5%, distributed nationwide in the US. The recall was initiated on 26 Jul 2018 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-1050-2018
- FDA event ID
- 80668
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Moxifloxacin
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Jul 2018
- FDA classified
- 8 Aug 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 26 Jul 2018 | Recall initiated by company | |
| 8 Aug 2018 | Classified by FDA | +13 days |
| 8 Aug 2018 | Published in enforcement report | +0 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: An out-of-specification result in the related substance test during three month long-term stability study.
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%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
Where it was distributed
Product was distributed throughout the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Which lots are affected?
Lot #: H800393, Exp. 01/2020
Where was it sold?
Product was distributed throughout the United States
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.
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | 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 |