Mylan Proctofoam HC Topical Aerosol Recall: Cgmp Deficiencies
Mylan recalls Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) 10g aerosol containers due to cGMP deficiencies. Rx only products distributed by Meda Pharmaceuticals.
Recall notice
cGMP deficiencies
Contact the company
What happened, in plain English
Mylan is recalling Proctofoam HC topical aerosol products with cGMP deficiencies. These prescription-only products may not meet quality standards and could pose risks to users. Read more at govinfonow.com/recall/35381-mylan-proctofoam-hc-topical-aerosol-recall-cgmp-deficiencies.
Source Summary by GovInfoNow · govinfonow.com/recall/35381-mylan-proctofoam-hc-topical-aerosol-recall-cgmp-deficiencies · Updated August 18, 2026 · FDA enforcement record: FDA #D-0452-2022
Cite this page
“Mylan Proctofoam HC Topical Aerosol Recall: Cgmp Deficiencies.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35381-mylan-proctofoam-hc-topical-aerosol-recall-cgmp-deficiencies. Based on FDA recall #D-0452-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0452-2022%22&limit=1).
Why it’s dangerous
The recall is due to cGMP (current Good Manufacturing Practice) deficiencies, which means the products may not meet quality standards. This could potentially affect the safety and effectiveness of the medication.
Who’s affected
Prescription users of Proctofoam HC aerosol products with the specified lot numbers and expiration dates. Those who have purchased these products from the listed distributor are most at risk.
How to tell if you have this one
Check the product label for the lot numbers 32925 (exp. May 2023), 33010 (exp. June 2023), 33119, and 33123 (exp. August 2023). The product is a prescription-only topical aerosol with NDC 0037-6822-10.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers 32925, 33010, 33119, or 33123 on the product label with expiration dates May 2023, June 2023, or August 2023.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Recalled product was distributed 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 terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-0452-2022 (January 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0452-2022 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.