Quality & complianceOfficial

FDA lists Class II recall of Aerocare Sani Mango hand and body wash over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Abc Compounding Co., Inc. is recalling the antiseptic wash nationwide under recall number D-0086-2027, which the FDA enforcement report shows as ongoing.

The US Food and Drug Administration has published a Class II drug recall for Aerocare Sani Mango Antiseptic Hand and Body Wash in its enforcement report dated 4 November 2026. The recalling firm is Abc Compounding Co., Inc.

The recall is recorded under number D-0086-2027, with the reason given as deviations from current good manufacturing practice (CGMP). The FDA lists the status as ongoing, meaning the recall action has not been closed.

Distribution is shown as US nationwide. The material available for this report does not include lot numbers, quantities, dates of manufacture or the specific nature of the CGMP deviations, so the extent of the affected product cannot be determined from it.

By way of 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 at compounders and contract manufacturers should note that CGMP deviations alone can lead to a nationwide recall of antiseptic products.
  • Distributors and retailers handling Aerocare Sani products should check the full FDA enforcement report entry for lot and code details, which are not covered here.
  • Regulatory affairs staff can track recall D-0086-2027 for any change in status, as it remains ongoing.

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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