CLASS II Drug recall · Reported 14 Aug 2019 · FDA Enforcement Report

Mometasone Furoate Cream recalled by Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Inc., USA is recalling Mometasone Furoate Cream USP, 0.1%, distributed nationwide in the US. The recall was initiated on 23 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 05171238, 05171248, 05171249, Exp. Jul-2019; 05171582, 05171612, Exp. Aug-2019; 05171674, 05171675, 05171682, Exp. Sep 2019; 05180065, 05180066, Exp. Dec 2019; 05180264, 05180264, 05180265, 05180275, 0518276, Exp. Jan 2020; 05180411, 05180412, 05180422, Exp. Jan 2020; 05180556, 05180568 Exp..Feb-2020; 05180889, 05180890, 05180896, 05180896, 05180897 Exp. Apr 2020; 05181123, 05181129, 05181134, 05181135, Exp. May 2020; 05181415, 05181425, 05181429, 05181433, Exp. Jun 2020; 05181528, Exp. Jul 2020; 05181747, 05181748, Exp. Aug 2020. b) 05171207, 05171212, 05171213, 05171232, 05171233, Exp. Jul-2019; 05171476, 05171478, 05171479, Exp. Aug 2019; 05171596 , 05171597, 05171602, 05171603, Exp. Aug 2019; 05171683, 05171697, 05171698, 05171703, 05171718, 05171783, 05171788, 05171789, 05171790, 05171791, Exp. Sep 2019; 05180092, 05180093, 05180119, 05180219, 05180220, Exp. Dec 2019; 05180289, 05180291, 05180434,05180435, Exp. Jan-2020; 05180438, 05180439, 05180443, 05180444, 05180450, 05180462, 05180572, 05180646, Exp. Feb 2020 05180648, 05180649, 05180659, 05180660, 05180671, Mar 2020; 05180870, 05180871, 05180874, 05180877, 05180900, 05180901, Exp. Apr 2020; 05181073, 05181074, 05181086, 05181087, 05181091, 05181092, 05181101, 05181102, 05181111, 05181146, 05181147, 05181148, 05181240 Exp. May 2020; 05181241, 05181248, 05181252, 05181253, 05181257, 05181265, 05181266, 05181267, 05181272, 05181309, 05181316, 05181317, 05181332 Exp. Jun 2020; 05181588, 05181602, 05181603, 05181618, 05181619, 05181621, 05181622, 05181633, 05181634 Exp. Jul 2020; 05181754, 05181772, 05181773, 05181781 Exp. Aug 2020

NDC68462-192

UPC0368462192559

Quantity recalledN/A

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-1586-2019
FDA event ID: 83413
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Brand: Mometasone Furoate
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jul 2019
FDA classified: 2 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Drug class: Creams, Ointments & Gels

Timeline

23 Jul 2019	Recall initiated by company
2 Aug 2019	Classified by FDA	+10 days
14 Aug 2019	Published in enforcement report	+12 days

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

Reason for recall

GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.

Which lots are affected?

a) 05171238, 05171248, 05171249, Exp. Jul-2019; 05171582, 05171612, Exp. Aug-2019; 05171674, 05171675, 05171682, Exp. Sep 2019; 05180065, 05180066, Exp. Dec 2019; 05180264, 05180264, 05180265, 05180275, 0518276, Exp. Jan 2020; 05180411, 05180412, 05180422, Exp. Jan 2020; 05180556, 05180568 Exp..Feb-2020; 05180889, 05180890, 05180896, 05180896, 05180897 Exp. Apr 2020; 05181123, 05181129, 05181134, 05181135, Exp. May 2020; 05181415, 05181425, 05181429, 05181433, Exp. Jun 2020; 05181528, Exp. Jul 2020; 05181747, 05181748, Exp. Aug 2020. b) 05171207, 05171212, 05171213, 05171232, 05171233, Exp. Jul-2019; 05171476, 05171478, 05171479, Exp. Aug 2019; 05171596 , 05171597, 05171602, 05171603, Exp. Aug 2019; 05171683, 05171697, 05171698, 05171703, 05171718, 05171783, 05171788, 05171789, 05171790, 05171791, Exp. Sep 2019; 05180092, 05180093, 05180119, 05180219, 05180220, Exp. Dec 2019; 05180289, 05180291, 05180434,05180435, Exp. Jan-2020; 05180438, 05180439, 05180443, 05180444, 05180450, 05180462, 05180572, 05180646, Exp. Feb 2020 05180648, 05180649, 05180659, 05180660, 05180671, Mar 2020; 05180870, 05180871, 05180874, 05180877, 05180900, 05180901, Exp. Apr 2020; 05181073, 05181074, 05181086, 05181087, 05181091, 05181092, 05181101, 05181102, 05181111, 05181146, 05181147, 05181148, 05181240 Exp. May 2020; 05181241, 05181248, 05181252, 05181253, 05181257, 05181265, 05181266, 05181267, 05181272, 05181309, 05181316, 05181317, 05181332 Exp. Jun 2020; 05181588, 05181602, 05181603, 05181618, 05181619, 05181621, 05181622, 05181633, 05181634 Exp. Jul 2020; 05181754, 05181772, 05181773, 05181781 Exp. Aug 2020

Where was it sold?

Nationwide within the United States

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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3 Jan 2024Drug	CLASS II	Asmanex Twisthaler (mometasone furoate inhalation powder recalledAsmanex	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
25 Jan 2023Drug	CLASS III	Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant recalledSinuva	Intersect ENT	Potency & Assay	Nationwide
13 Jul 2022Drug	CLASS III	Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a)-bottle recalledMometasone Furoate	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide