The Recall Desk
LowFDA (Drugs)·D-1743-2019·Announced 2019-08-21

Glenmark Recalls Clotrimazole and Betamethasone Cream Due to Temperature Abuse

Glenmark Pharmaceuticals is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream due to complaints of a liquidy texture caused by temperature abuse.

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, fitting the 'Low' severity criteria for cosmetic or packaging-only issues.

Plain-English summary

Glenmark Pharmaceuticals Inc. is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes. The product is a prescription-only topical cream manufactured in India for Glenmark Pharmaceuticals Inc. in the United States. The specific lot number is 05180734 with an expiration date of 03/2020.

The recall was initiated due to complaints regarding a liquidy texture in the product, which the source attributes to temperature abuse. The agency has classified this as a Class III recall, indicating that the product is not likely to cause adverse health consequences.

The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE)
Brand
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Affected units
31,224

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 (2)

  • Lot #: 05180734
  • Exp. 03/2020

UPCs (2)

  • 0368462298176
  • 0368462298558

Distribution

Distributed nationwide across the United States.

Same brand · CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE