CLASS III Drug recall · Reported 24 Jul 2019 · FDA Enforcement Report

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recalled

Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, distributed nationwide in the US. The recall was initiated on 11 Jul 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: H805157, Exp. 05/2020

Quantity recalled17,238 bottles

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-1490-2019
FDA event ID: 83333
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Classification: Class III
Status: Terminated
Recall initiated: 11 Jul 2019
FDA classified: 17 Jul 2019
Reported: 24 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Drug class: Eye Drops

Timeline

11 Jul 2019	Recall initiated by company
17 Jul 2019	Classified by FDA	+6 days
24 Jul 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Missing label; Product complaints reported missing bottle label.

Product as listed by the FDA

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.

Where it was distributed

Nationwide in the U.S. and PR.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Labeling: Missing label; Product complaints reported missing bottle label.

Which lots are affected?

Lot #: H805157, Exp. 05/2020

Where was it sold?

Nationwide in the U.S. and PR.

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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Other Gatifloxacin recalls

All 5

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
22 Jan 2014Drug	CLASS II	Gatifloxacin 0.5% (ophthalmic) recalled by Specialty Medicine	Specialty Medicine Compounding Pharmacy	Sterility	MI