CLASS III Drug recall · Reported 3 Nov 2021 · FDA Enforcement Report
Gatifloxacin Ophthalmic Solution recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution, 0.5%, distributed nationwide in the US. The recall was initiated on 20 Oct 2021 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-0091-2022
- FDA event ID
- 88885
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Oct 2021
- FDA classified
- 2 Nov 2021
- Reported
- 3 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 20 Oct 2021 | Recall initiated by company | |
| 2 Nov 2021 | Classified by FDA | +13 days |
| 3 Nov 2021 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
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
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Which lots are affected?
Lot # H002512, exp. date March 2022
Where was it sold?
Nationwide in the USA and Puerto Rico
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 II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
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Other Gatifloxacin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Gatifloxacin Ophthalmic Solution recalled by Lupin Pharmaceuticals | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recalledGatifloxacin | Sandoz | Packaging Defects | Nationwide |
| Drug | CLASS III | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recalled | Lupin Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | Gatifloxacin 0.5% (ophthalmic) recalled by Specialty Medicine | Specialty Medicine Compounding Pharmacy | Sterility | MI |