CLASS III Drug recall · Reported 6 Mar 2019 · 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 Feb 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020

NDC68180-422

UPC0368180422013

Quantity recalled674,628 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-0517-2019
FDA event ID: 82249
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Brand: Moxifloxacin
Manufacturer: Lupin Pharmaceuticals, Inc.
Classification: Class III
Status: Terminated
Recall initiated: 26 Feb 2019
FDA classified: 28 Feb 2019
Reported: 6 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Eye Drops

Timeline

26 Feb 2019	Recall initiated by company
28 Feb 2019	Classified by FDA	+2 days
6 Mar 2019	Published in enforcement report	+6 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: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

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%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

Where it was distributed

Nationwide in the USA and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

Which lots are affected?

Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020

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

All 123

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate	Lupin Pharmaceuticals	Other	Nationwide
8 Jul 2026Drug	CLASS II	prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate	Lupin Pharmaceuticals	Other	Nationwide
8 Jul 2026Drug	CLASS II	Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon	Lupin Pharmaceuticals	Potency & Assay	Nationwide
27 May 2026Drug	CLASS II	Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide	Lupin Pharmaceuticals	Particulate Matter	Nationwide
17 Dec 2025Drug	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
5 Jun 2024Drug	CLASS II	Moxifloxacin 0.8 mg/ Preservative-Free Single-Use vials recalled	Imprimis Njof	Sterility	Nationwide
5 Jun 2024Drug	CLASS II	Moxifloxacin 4 mg/ Preservative-Free Single-Use vials recalled	Imprimis Njof	Sterility	Nationwide
6 Mar 2024Drug	CLASS II	Moxifloxacin 5mg/ml in a Single- Dose Vial recalled by Denver Solutions	Denver Solutions	Particulate Matter	Nationwide
25 Oct 2023Drug	CLASS II	Moxifloxacin in Balanced Salt Solution, Solution recalled	Pine Pharmaceuticals	Sterility	Nationwide
25 Oct 2023Drug	CLASS II	Moxifloxacin in Balanced Salt Solution 400 mcg/ (100 mcg/ syringes recalled	Pine Pharmaceuticals	Sterility	Nationwide