Edge Pharma recalls 1% Dibutyl Squaric Acid topical solution vials produced between August 2021 and February 2022 due to manufacturing quality issues. Consumers should check product details and contact the company for updates.
CGMP Deviations
Edge Pharma is recalling 1% Dibutyl Squaric Acid topical solution vials that were manufactured between August 2021 and February 2022. The recall is due to CGMP deviations, which means the product may not meet safety standards.
CGMP deviations refer to failures in the manufacturing process that could lead to the product not meeting safety and quality standards. This means the topical solution might not be as safe as it should be, potentially causing skin irritation or other issues.
People who own or use the recalled topical solution vials are affected. Those with sensitive skin or using the product for medical purposes may be at higher risk.
Check for the product name 'Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial' on the label. The recall covers vials manufactured between August 2021 and February 2022.
Look for the product name and manufacturing date on the label to confirm if it's recalled.
The recall is due to CGMP deviations, which means the product may not meet safety standards. It is recommended to stop using it until further notice.
Check the product label for the name 'Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial' and the manufacturing date between August 2021 and February 2022.
The recall does not specify a remedy, so contact Edge Pharma directly for further instructions.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0435-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0435-2022 from Edge Pharma. 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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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.