Quality & complianceOfficial

FDA lists Class II recall of Abc Compounding's FM-24 Foaming antiseptic hand and body wash

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The recall, classified for CGMP deviations, is ongoing and covers product distributed across the US, according to the FDA enforcement report.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report for People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash, made by Abc Compounding Co., Inc. The entry is dated 4 November 2026.

The recall is numbered D-0096-2027 and is attributed to deviations from current good manufacturing practice (CGMP). The enforcement report's status field shows the recall as ongoing.

Distribution is recorded as US nationwide. The material available to us does not set out the specific CGMP failings, the quantity of product involved, lot numbers or expiry dates, nor does it say how the firm is notifying customers or consumers.

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 supplying or sourcing antiseptic washes from compounders should check whether recalled product is in their supply chain and review supplier CGMP oversight.
  • Regulatory affairs staff should consult the full enforcement report entry for the reason for recall, lot details and quantities, which are not covered here.
  • Because the recall is ongoing, its status and scope could change, so the FDA database is worth monitoring 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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