Mylan Proctofoam HC Topical Aerosol Recall: Cgmp Deficiencies

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Recalling firmMylan Pharmaceuticals Inc3711 Collins Ferry Rd · Morgantown, WV 26505-2362

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✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

Mylan Pharmaceuticals Inc. is recalling Proctofoam HC due to cGMP deficiencies, which means the products may not meet quality standards.

What is the product name?

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10g containers.

How do I know if I have the recalled product?

Check the product label for lot numbers 32925 (exp. May 2023), 33010 (exp. June 2023), 33119, or 33123 (exp. August 2023).

Take action

Contact Mylan

We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0452-2022 — Mylan Mylan

Hello,

I own a Mylan that is covered by recall D-0452-2022 from Mylan.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Mylan Pharmaceuticals Inc recalls Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx

Recall notice