Quality & complianceOfficial

FDA lists Class II recall of Abc Compounding antiseptic hand soap over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The recall, numbered D-0091-2027, is ongoing and covers product distributed across the United States, according to the FDA's enforcement report.

The US Food and Drug Administration has entered a Class II recall of Antiseptic Hand Soap, made by Abc Compounding Co., Inc., in its enforcement report dated 4 November 2026.

The recall is filed under number D-0091-2027 and the stated reason is deviations from current good manufacturing practice (CGMP). The FDA lists its status as ongoing, and distribution is described as US nationwide.

The page text available to VigiEye was largely search-tool navigation and did not include the product's lot numbers, quantities, dates of manufacture or the specific CGMP failings. It also gave no details on the firm's recall strategy or on any reported adverse events.

For context, the FDA assigns Class II to recalls where use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams should check the full FDA enforcement report entry for lot and code information, which was not available in the source text reviewed.
  • Compounders and OTC antiseptic manufacturers may wish to review their own CGMP controls, as this recall rests on CGMP deviations rather than a named contaminant or defect.
  • Supply chain and distribution teams handling antiseptic hand soap should confirm whether any affected product is in their inventory, given the nationwide distribution.
  • As the recall is ongoing, its scope or classification details may be updated by the FDA.

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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