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FDA lists Class II recall of Handtastic Foamy Mango antiseptic foam soap over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Abc Compounding Co., Inc.'s hand and body wash is subject to recall D-0095-2027, which is ongoing and covers nationwide US distribution, according to the FDA enforcement report.

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

The recall carries the number D-0095-2027 and is categorised as a current good manufacturing practice (CGMP) deviations recall. Its status is listed as ongoing, meaning the recall action has not yet been closed.

Distribution is recorded as US nationwide. The material available to us does not set out the specific nature of the CGMP deviations, the affected lot numbers, the quantities involved or the date the recall began, so those details cannot be reported here.

As general 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 contract and compounding manufacturers of topical antiseptics should note that CGMP deviations alone can trigger a nationwide recall.
  • Regulatory affairs staff tracking the product should consult the full FDA enforcement report entry for recall D-0095-2027 for product codes, lot details and the firm's stated reason.
  • Distributors and retailers handling the product should check recall notification channels, given the nationwide distribution and the ongoing status.

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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