Quality & complianceOfficial

FDA lists Class II recall of Spurrier by Abc Compounding over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The US regulator's enforcement report records an ongoing, nationwide Class II drug recall, numbered D-0101-2027, citing deviations from current good manufacturing practice.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report, dated 4 November 2026. The entry is titled Spurrier and names Abc Compounding Co., Inc. as the firm concerned.

The recall carries the number D-0101-2027 and is attributed to CGMP deviations, meaning departures from current good manufacturing practice. Its status is listed as ongoing, and distribution is described as US nationwide.

The material available gives no further detail. It does not state the product's strength or dosage form, affected lots or expiry dates, quantities, or the specific nature of the deviations. It also does not say when the recall started.

As general 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 probability of serious harm is remote.

What it means for your team

  • Teams handling compounded or outsourced products supplied in the US should check whether any Spurrier product from Abc Compounding Co., Inc. is in their supply chain.
  • Quality teams should consult the full FDA enforcement report entry for D-0101-2027 for lot and product details, which are not covered here.
  • The recall is ongoing, so its status and scope may change; check the FDA record 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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