The Recall Desk
ModerateFDA (Drugs)·D-1586-2019·Announced 2019-08-14

Glenmark Recalls Mometasone Furoate Cream Due to Gritty Texture Complaints

Glenmark Pharmaceuticals is recalling Mometasone Furoate Cream 0.1% because patients reported the product felt gritty. The recall covers 15g and 45g tubes distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific complaint of a gritty texture suggests a quality deviation rather than a severe safety hazard like contamination or mislabeling of active ingredients.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Mometasone Furoate Cream USP, 0.1%, in 15-gram and 45-gram tubes. The recall was initiated after the company received complaints stating that the cream was gritty.

The affected product is a prescription-only topical medication manufactured in India and distributed nationwide within the United States. The recall includes specific lot numbers with expiration dates ranging from July 2019 to August 2020.

Consumers should stop using the affected product and return it to their pharmacy or contact Glenmark Pharmaceuticals for instructions on how to proceed.

The recalled product

Product
MOMETASONE FUROATE (MOMETASONE FUROATE)
Brand
MOMETASONE FUROATE

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) 05171238
  • 05171248
  • 05171249
  • Exp. Jul-2019
  • 05171582
  • 05171612
  • Exp. Aug-2019
  • 05171674
  • 05171675
  • 05171682
  • Exp. Sep 2019
  • 05180065
  • 05180066
  • Exp. Dec 2019
  • 05180264
  • 05180265
  • 05180275
  • 0518276
  • Exp. Jan 2020
  • 05180411

UPCs (1)

  • 0368462192559

Distribution

Distributed nationwide across the United States.

Same brand · MOMETASONE FUROATE