Quality & complianceOfficial

FDA lists Class II recall of Freshhands antibacterial foamy hand soap over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Abc Compounding Co., Inc. is recalling Freshhands Premium Foamy Antibacterial Hand Soap Antiseptic nationwide, with the action classed as Class II and still ongoing.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report for Freshhands Premium Foamy Antibacterial Hand Soap Antiseptic. The recalling firm is Abc Compounding Co., Inc. The entry is dated 4 November 2026 and carries recall number D-0089-2027.

The recall is attributed to deviations from current good manufacturing practice (CGMP). Its status is listed as ongoing, and distribution is given as US nationwide.

The enforcement report entry available to VigiEye did not include further detail, such as the specific nature of the CGMP deviations, product quantities, lot numbers or the date the recall began. We therefore cannot say what the deviations involved or which batches are affected.

As general context, the FDA assigns Class II to recalls where using or being exposed to the product may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is remote.

What it means for your team

  • Quality teams should check whether any antiseptic hand soap from this firm appears in their supply chains or sites, and consult the full FDA record for product and lot details.
  • The CGMP reason is a reminder that contract and compounding suppliers of topical antiseptics are subject to manufacturing-quality oversight and recall action.
  • As the recall is ongoing, details and scope may change; teams should monitor the FDA enforcement report for updates.

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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