Quality & complianceOfficial

FDA lists Class II recall of Lynx from 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 of Lynx, attributed to current good manufacturing practice deviations at ABC Compounding Co., Inc.

The US Food and Drug Administration has published a Class II drug recall entry for Lynx, a product from ABC Compounding Co., Inc., in its enforcement report dated 4 November 2026. The recall is numbered D-0094-2027.

The stated reason for the recall is deviations from current good manufacturing practice (CGMP). The recall's status is listed as ongoing, meaning the action has not yet been closed.

Distribution is described as US nationwide. The material available for this report does not include the product's strength, dosage form, lot numbers, expiry dates, quantities or the date the firm initiated the recall, so those details cannot be confirmed here.

For 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 adverse consequences is remote.

What it means for your team

  • Compounding and outsourcing partners should check whether any Lynx supplied by ABC Compounding is in their inventory or supply chain, using the full FDA enforcement report entry for lot-level detail.
  • Quality teams may wish to review supplier qualification and audit files for CGMP compliance where they use compounded products.
  • Because the recall is ongoing and nationwide, the entry may be updated; teams should monitor the FDA enforcement report for changes in status or scope.

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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