Quality & complianceOfficial

FDA classifies Abc Compounding antiseptic hand and body wash recall as Class II over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The nationwide recall of Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, logged as D-0087-2027, remains ongoing in the FDA's enforcement report.

The US Food and Drug Administration has published a Class II recall for Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, made by Abc Compounding Co., Inc. The entry appears in the agency's enforcement report dated 4 November 2026.

The recall is numbered D-0087-2027 and is attributed to deviations from current good manufacturing practice (CGMP). The FDA lists its status as ongoing, and distribution is described as US nationwide.

The text available for this item is largely search-page navigation and does not include the product's lot numbers, quantities, dates of distribution or the specific CGMP failings. It also gives no detail on how the firm is notifying customers or whether any adverse events have been reported.

For context, the FDA assigns a Class II classification 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 of topical antiseptics should note that CGMP deviations alone can trigger a nationwide recall.
  • Distributors and retailers holding Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash should check the full FDA enforcement report entry for lot and code information, which is not in the available text.
  • Regulatory affairs staff can track the ongoing status of D-0087-2027 for any later termination or update.

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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