Gatifloxacin recalls

The FDA has published 5 recalls involving Gatifloxacin since 2014. The latest was reported on 12 Jan 2022. Most were for potency & assay. Lupin Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 12 Jan 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 1 20%Class III 4 80%

Why gatifloxacin is recalled

Companies

Lupin Pharmaceuticals360%
Specialty Medicine Compounding Pharmacy120%
Sandoz120%

By year

2022120%
2021120%
2019240%
2014120%

All gatifloxacin recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
12 Jan 2022Drug	CLASS III	Gatifloxacin Ophthalmic Solution recalled by Lupin Pharmaceuticals	Lupin Pharmaceuticals	Potency & Assay	Nationwide
3 Nov 2021Drug	CLASS III	Gatifloxacin Ophthalmic Solution recalled by Lupin Pharmaceuticals	Lupin Pharmaceuticals	Potency & Assay	Nationwide
6 Nov 2019Drug	CLASS III	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recalledGatifloxacin	Sandoz	Packaging Defects	Nationwide
24 Jul 2019Drug	CLASS III	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recalled	Lupin Pharmaceuticals	Labeling Errors	Nationwide
22 Jan 2014Drug	CLASS II	Gatifloxacin 0.5% (ophthalmic) recalled by Specialty Medicine	Specialty Medicine Compounding Pharmacy	Sterility	MI

Should you stop taking Gatifloxacin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.