The Recall Desk
LowFDA (Drugs)·D-1173-2022·Announced 2022-07-13

Mometasone Furoate Topical Solution Recalled Due to Defective Containers

Glenmark Pharmaceuticals is recalling Mometasone Furoate Topical Solution USP 0.1% due to defective containers. Approximately 98,307 packs were distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: FDA Class III recalls are typically scored as 1 or 2 per the severity rubric. This recall involves a defective container with no reported illnesses or injuries, placing it in the packaging-only problems category, which receives a Score 1 (Low).

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Mometasone Furoate Topical Solution USP, 0.1% Lotion in 30 ml and 60 ml bottles. This recall affects approximately 98,307 packs distributed nationwide in the United States due to defective containers.

The specific lots affected are identified by lot number and expiration date. For 30 ml bottles, affected lots include 05201358 (06/2022), 05210287 and 05210288 (01/2023), 05211446 (07/2023), 05211704 and 05211714 (08/2023), and 05212217 (10/2023). For 60 ml bottles, affected lots include 05201358 (06/2022), 05210287, 05210288, and 05210424 (01/2023), 05210425 and 05210435 (02/2023), 05211427, 05211439, and 05211445 (07/2023), 05211723, 05211731, 05211850, and 05211864 (08/2023), and 05212226, 05212250, and 05212261 (10/2023).

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance regarding replacement or alternatives. The recall was voluntarily initiated by the manufacturer and was classified as a Class III recall.

The recalled product

Product
MOMETASONE FUROATE (MOMETASONE FUROATE)
Brand
MOMETASONE FUROATE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Topical
Hazard
  • container-defect

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)

  • Lot # a) 05201358
  • Exp 06/2022
  • 05210287
  • 05210288
  • Exp 01/2023
  • 05211446
  • Exp 07/2023
  • 05211704
  • 05211714
  • Exp 08/2023
  • 05212217
  • Exp 10/2023: b) 05201358
  • Exp 06/2022
  • 05210424
  • 05210425
  • 05210435
  • Exp 02/2023
  • 05211427
  • 05211439
  • 05211445

UPCs (1)

  • 0368462385371

Distribution

Distributed nationwide across the United States.

Related recalls

Same category