CLASS III Drug recall · Reported 12 Jan 2022 · 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 22 Dec 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022

Quantity recalled50,832 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-0326-2022
FDA event ID: 89268
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Classification: Class III
Status: Terminated
Recall initiated: 22 Dec 2021
FDA classified: 4 Jan 2022
Reported: 12 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Eye Drops

Timeline

22 Dec 2021	Recall initiated by company
4 Jan 2022	Classified by FDA	+13 days
12 Jan 2022	Published in enforcement report	+8 days

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

Nationwide 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 #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 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.

More recalls from Lupin Pharmaceuticals

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Other Gatifloxacin recalls

All 5

Reported	Class	Recall	Company	Reason	Where
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