Quality & complianceOfficial

FDA lists Class II recall of Chemseptic from Abc Compounding over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The nationwide recall, numbered D-0100-2027, is classed as ongoing in the FDA enforcement report dated 4 November 2026.

The US Food and Drug Administration has published a Class II drug recall entry for Chemseptic, made by Abc Compounding Co., Inc. The entry appears in the agency's enforcement report dated 4 November 2026.

The recall is filed under number D-0100-2027, and the stated reason is deviations from current good manufacturing practice (CGMP). The FDA lists its status as ongoing, which means the recall action has not yet been closed.

Distribution is recorded as US nationwide. The material available to VigiEye does not include the product's strength or dosage form, lot numbers, expiry dates, quantities or a description of the specific CGMP failures, so the scale and nature of the problem cannot be assessed from it.

By way of context, the FDA assigns Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is remote.

What it means for your team

  • Teams that supply, stock or use Chemseptic in the US should check the full enforcement report entry for lot details and recall instructions.
  • The listing gives no detail on the CGMP deviations, so quality teams cannot yet judge whether the issues relate to wider compounding or manufacturing practices.
  • Because the recall is ongoing, its status or scope may change. Monitor later enforcement reports 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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