The Recall Desk
LowFDA (Drugs)·D-0618-2020·Announced 2019-12-18

Glenmark Recalls Clobetasol Propionate Foam Due to Defective Delivery System

Glenmark Pharmaceuticals is recalling Clobetasol Propionate Foam because the product is not foaming or is coming out as liquid.

What this means for you

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

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a functional defect in the delivery system rather than a contamination or safety hazard.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Clobetasol Propionate Foam, 0.05%, in 50 g and 100 g packs. The recall is due to a defective delivery system where the product is not foaming or is coming out as liquid.

The affected product is a prescription-only topical medication manufactured by Glenmark Pharmaceuticals Ltd. in India for Glenmark Pharmaceuticals Inc. in the USA. The recall covers specific lot numbers with expiration dates ranging from February 2021 to July 2021.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.

The recalled product

Product
CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
Brand
CLOBETASOL PROPIONATE

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 (15)

  • a) 14190026
  • 14190028
  • 14190029
  • exp Feb-2021
  • 14190043
  • 14190045 exp Apr-2021 b) 14190024
  • 14190025
  • 14190027
  • 14190030
  • 14190031
  • exp Mar-2021
  • 14190039
  • 14190042 exp Apr-2021
  • 14190047 exp May-2021
  • 14190062 exp Jul-2021

UPCs (1)

  • 0368462608944

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →