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Lower risk Drug recall · FDA · Published January 14, 2022

Mayne Pharma Lexette Foam Recall: Difficulty dispensing or liquid instead of foam

Mayne Pharma recalls Lexette (halobetasol propionate) 0.05% topical foam canisters due to difficulty dispensing or dispensing liquid instead of foam. This is a CGMP deviation affecting certain lots.

🇺🇸 FDA recall #D-0387-2022DrugMayne Pharma ›
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Recalling firmMayne Pharma Inc1240 Sugg Pkwy · Greenville, NC 27834-9006
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mayne Pharma is recalling Lexette topical foam canisters that may not dispense correctly or dispense liquid instead of foam. This could lead to improper medication application and potential treatment failure. Read more at govinfonow.com/recall/35387-mayne-pharma-lexette-foam-recall-difficulty-dispensing-or-liquid-instead.

Source Summary by GovInfoNow · govinfonow.com/recall/35387-mayne-pharma-lexette-foam-recall-difficulty-dispensing-or-liquid-instead · Updated August 18, 2026 · FDA enforcement record: FDA #D-0387-2022

Cite this page

“Mayne Pharma Lexette Foam Recall: Difficulty dispensing or liquid instead of foam.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35387-mayne-pharma-lexette-foam-recall-difficulty-dispensing-or-liquid-instead. Based on FDA recall #D-0387-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0387-2022%22&limit=1).

Why it’s dangerous

The product has a CGMP deviation where it may not dispense properly as foam or dispenses liquid instead. This could result in incorrect medication application, potentially reducing effectiveness or causing unintended side effects.

Who’s affected

Prescription users of Lexette topical foam who received the recalled canisters from Mayne Pharma in Greenville, NC. Those with specific lot numbers and expiration dates listed in the recall are most affected.

How to tell if you have this one

Check the canister label for the product name 'Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g'. Look for lot numbers 32451, 32532, 32552, 32701, 32733, 32855, or 32872 with expiration dates up to 03/2022 through 03/2023.

  • Brand
    Mayne Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the lot numbers 32451, 32532, 32552, 32701, 32733, 32855, or 32872 on the canister.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 12 days after the firm started it.

1. Firm started the recall: Jan 14, 202212. FDA classified it Class II: Jan 19, 202223. Published in FDA’s Enforcement Report: Jan 26, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury from this product?

The recall is for a manufacturing issue that could affect medication application, but there is no indication of serious injury risk in normal use.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0387-2022 (January 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0387-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA