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Unrated Drug recall · FDA · Published January 10, 2022

Ingenus Clobetasol Foam Recall: CGMP Deviations in 50g and 100g Cans

Ingenus Pharmaceuticals recalls 0.05% clobetasol propionate foam cans due to CGMP deviations. Affected lots expired by June 2022. No remedy stated in official notice.

🇺🇸 FDA recall #D-0374-2022DrugIngenus Pharmaceuticals ›
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Recalling firmIngenus Pharmaceuticals Llc4190 Millenia Blvd · Orlando, FL 32839-6408
✎ GovInfoNow plain-language explainer

What happened, in plain English

Ingenus Pharmaceuticals is recalling two sizes of prescription clobetasol propionate foam for potential CGMP deviations. This recall means the product may not meet quality standards, though no specific safety risks are described in the notice. Read more at govinfonow.com/recall/35391-ingenus-clobetasol-foam-recall-cgmp-deviations-in-50g-and-100g.

Source Summary by GovInfoNow · govinfonow.com/recall/35391-ingenus-clobetasol-foam-recall-cgmp-deviations-in-50g-and-100g · Updated August 18, 2026 · FDA enforcement record: FDA #D-0374-2022

Cite this page

“Ingenus Clobetasol Foam Recall: CGMP Deviations in 50g and 100g Cans.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35391-ingenus-clobetasol-foam-recall-cgmp-deviations-in-50g-and-100g. Based on FDA recall #D-0374-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0374-2022%22&limit=1).

Why it’s dangerous

CGMP deviations refer to failures in manufacturing quality control processes. This could mean the product does not meet the required safety and purity standards for prescription use. However, the recall notice does not specify how this affects safety or health.

Who’s affected

Prescription users of 50g and 100g clobetasol propionate foam cans with specific expiration dates. People using the product for skin conditions may be affected if they have the recalled lots.

How to tell if you have this one

Check for 50g or 100g cans labeled with NDC 50742-304-50 or 50742-304-01. Look for expiration dates: June 2022, August 2022, or November 2022.

  • Brand
    Ingenus Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by checking the NDC code and expiration date on the can.

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 in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Jan 10, 202212. FDA classified it Class II: Jan 14, 202223. Published in FDA’s Enforcement Report: Jan 26, 202234. FDA terminated the recall: Aug 15, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0374-2022 (January 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0374-2022 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