The Recall Desk
ModerateFDA (Drugs)·D-0426-2019·Announced 2019-02-13

US Pharmaceuticals Recalls Hydrocortisone Cream Due to Microbial Contamination

US Pharmaceuticals is recalling Hydrocortisone Cream Intensive Healing due to out-of-specification microbial counts in purified water.

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 and involves a low-risk contamination (microbial count in excipient) without reported illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

US Pharmaceuticals Inc. is recalling Hydrocortisone Cream Intensive Healing (Hydrocortisone Cream 1%) 2 oz tubes, distributed by Walgreen Co. The recall involves 67,848 units distributed nationwide within the United States.

The recall was initiated due to Good Manufacturing Practice (GMP) deviations, specifically out-of-specification results for Total Aerobic Microbial count in an excipient purified water sample. The affected lots are 36G17 and 47G17 (Expiration 5/2019) and 84J17 (Expiration 7/2019).

Consumers with these products should stop using them and return them to the point of purchase or contact the manufacturer for instructions.

The recalled product

Product
HYDROCORTISONE CREAM INTENSIVE HEALING (HYDROCORTISONE CREAM)
Brand
HYDROCORTISONE CREAM INTENSIVE HEALING
Affected units
67,848

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 (5)

  • Lot #: 36G17
  • 47G17
  • Exp. 5/2019
  • 84J17
  • Exp. 7/2019

UPCs (1)

  • 0311917187297

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by US Pharmaceuticals Inc. 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 3 products in this recall →