The Recall Desk
HighFDA (Drugs)·D-0847-2022·Announced 2022-05-11

Halobetasol Propionate Ointment 0.05% Recalled Due to Manufacturing Practice Deviations

McKesson Corporation is recalling Halobetasol Propionate Ointment 0.05% nationwide after the manufacturer discontinued its stability study program, creating CGMP deviations. Over 13,200 tubes distributed in the United States, Guam, and the Northern Mariana Islands are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall due to CGMP deviations related to the manufacturer's discontinuation of its stability study program. No illnesses or injuries have been reported, but the unverified stability of this topical corticosteroid poses a risk to consumers and fits the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

McKesson Corporation is recalling Halobetasol Propionate Ointment 0.05% in 50-gram tubes. The affected lots are: Lot 15720 (expires 06/30/2022), Lot 16449 (expires 02/28/2023), and Lot 16450 (expires 02/26/2023).

The recall was initiated because Teligent Pharma, Inc., the manufacturer, discontinued its stability study program. This discontinuation constitutes a deviation from Current Good Manufacturing Practice (CGMP) requirements. The FDA requires drug manufacturers to maintain ongoing stability studies to ensure products maintain their safety and effectiveness throughout their labeled shelf life.

The affected product was distributed nationwide in the United States, including Guam and the Northern Mariana Islands. All products within expiry dates are included in the recall. Over 13,200 tubes were distributed.

If you have this product, stop using it and contact your healthcare provider or pharmacist for guidance on an alternative. Do not dispose of the medication in household trash or by flushing it down the toilet. Instead, follow your local pharmacy's medication take-back program or use an FDA-approved drug disposal method.

The recalled product

Product
Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
Manufacturer
McKesson Corporation dba McKesson Drug Company
Category
Drug — Topical Corticosteroid
Hazard
  • cgmp-deviation
  • stability-not-verified

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)

  • Lots: 15720
  • Exp.: 06/30/2022
  • 16449 Exp.: 02/28/2023
  • 16450
  • Exp.: 02/26/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category