Quality & complianceOfficial

FDA lists Class II recall of Surgent antiseptic hand soap over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

An enforcement report entry records an ongoing nationwide recall of SunCoast Paper's Surgent Antiseptic Hand Soap, linked to Abc Compounding Co., Inc. and cited for CGMP deviations.

The US Food and Drug Administration has published a Class II drug recall entry for Surgent Antiseptic Hand Soap, a product listed under SunCoast Paper Inc. The recall appears in the agency's enforcement report dated 4 November 2026 under the number D-0102-2027.

The stated reason is deviations from current good manufacturing practice (CGMP). The entry also names Abc Compounding Co., Inc. in connection with the product. The material available does not explain which CGMP requirements were not met, and it gives no detail on the products affected.

The recall's status is ongoing, and distribution is described as US nationwide. The text supplied does not include product lot numbers, quantities, the date the recall began or any information on illness, injury or complaints, so the scale and practical risk cannot be gauged from it.

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 at distributors and purchasers of Surgent Antiseptic Hand Soap should check the full FDA enforcement report entry for lot and code details before acting.
  • Because the recall is ongoing and nationwide, supply chain and procurement staff may need to verify whether affected stock is held in US facilities.
  • The CGMP classification is a reminder that compounding and contract manufacturing relationships remain a focus of GMP oversight; the source gives no specific findings.
  • Teams should not infer the root cause, patient impact or scope beyond what the FDA entry states.

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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