The Recall Desk
ModerateFDA (Drugs)·D-0387-2022·Announced 2022-01-26

Lexette Topical Foam Recall Due to Dispensing Defects

Mayne Pharma is recalling Lexette (halobetasol propionate) Topical Foam 0.05% due to manufacturing defects that cause the product to either not dispense or dispense liquid instead of foam. The recall affects 17,113 canisters distributed nationwide.

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: This is an FDA Class II recall involving a manufacturing defect that affects product functionality. No injuries or illnesses are reported in the source text, and the hazard is a dispensing defect rather than a safety hazard like contamination or toxicity. This qualifies as a moderate-severity voluntary recall grounded in a manufacturing deviation.

Plain-English summary

Mayne Pharma Inc is recalling Lexette (halobetasol propionate) Topical Foam 0.05%, 50 g canisters (NDC 51862-604-50), distributed nationwide by Mayne Pharma Greenville, NC. The recall was initiated due to a current Good Manufacturing Practice (CGMP) deviation involving defects in product dispensing.

The affected canisters may either fail to dispense the product entirely or may dispense liquid instead of foam. This defect compromises the product's intended functionality as a topical foam medication. The recall involves 17,113 canisters across multiple lot numbers with expiration dates ranging from March 2022 through March 2023: Lot #32451 (Exp. 03/2022), 32532 (Exp. 04/2022), 32552 (Exp. 05/2022), 32701 and 32733 (Exp. 10/2022), 32855 (Exp. 02/2023), and 32872 (Exp. 03/2023).

Consumers or healthcare providers in possession of affected Lexette Topical Foam canisters should stop use and contact Mayne Pharma. Patients should consult their healthcare provider regarding alternative treatment options for their condition.

The recalled product

Product
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Manufacturer
Mayne Pharma Inc
Category
Drug — Topical / Corticosteroid
Hazard
  • dispensing-defect
  • manufacturing-deviation

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 (6)

  • Lot #: 32451 Exp. 03/2022
  • 32532 Exp. 04/2022
  • 32552 Exp. 05/2022
  • 32701 32733 Exp. 10/2022
  • 32855 Exp. 02/2023
  • 32872 Exp. 03/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category