Quality & complianceOfficial

FDA lists Class II recall of ABC Compounding's Palm Antiseptic Hand Soap over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The US regulator's enforcement report records an ongoing, nationwide recall of 1-gallon Palm Antiseptic Hand Soap, classed as Class II and attributed to CGMP deviations.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report dated 4 November 2026. It covers Palm Antiseptic Hand Soap, sold in a net contents size of 1 gallon (3.8 litres).

The product is listed as manufactured by ABC Compounding (ABC Compounding Co., Inc.). The recall carries the number D-0085-2027, and the stated reason is deviations from current good manufacturing practice (CGMP).

The entry gives the recall's status as ongoing and its distribution as US nationwide. The material available for this report does not include lot numbers, quantities, the dates of the recall's initiation or any description of the specific CGMP failures.

As background, FDA assigns Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the chance of serious harm is remote.

What it means for your team

  • Quality teams handling antiseptic or hand-hygiene products from ABC Compounding should check their supply chains against recall D-0085-2027 in the full FDA enforcement report.
  • The CGMP deviation classification is a reminder that contract and compounding suppliers need current audit and qualification records, including for OTC-type topical products.
  • Details such as lot numbers and the nature of the deviations are not in the summary available here, so teams should consult the full FDA record before acting.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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