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ABC Compounding's Lynx pulled across US in open-ended Class II recall

An FDA enforcement entry shows a nationwide recall of Lynx, made by ABC Compounding Co., Inc., remains unresolved, with manufacturing-practice failings cited as the cause.

04 Nov 2026 · FDA enforcement report · Regulator

ABC Compounding Co., Inc. is the subject of a live nationwide drug recall, according to the US Food and Drug Administration's enforcement report of 4 November 2026. The entry covers a product called Lynx and carries the recall number D-0094-2027.

The agency attributes the action to departures from current good manufacturing practice, the baseline quality standard for making medicines. The recall is classed as Class II and its status is listed as ongoing, so it has not been formally closed. Distribution is given as US nationwide.

For context, the FDA applies Class II where exposure to a product may cause temporary or medically reversible harm, or where the chance of serious harm is considered remote. It is a lower tier than Class I, which is reserved for the most serious risks.

Much of the commercial picture is missing. The information available does not specify Lynx's strength or dosage form, lot numbers, expiry dates, quantities or the date ABC Compounding began the recall. It also gives no indication of sales at stake, customers affected or any financial impact on the firm, so the scale of the disruption cannot be gauged from this entry alone.

Because the recall is open, the listing could be revised as the status or scope changes. Anyone holding product from the firm would need the full enforcement report record for lot-level detail.

Why it matters

  • Compounders and outsourcing partners should check whether Lynx from ABC Compounding sits in their inventory or supply chain.
  • Quality teams using compounded products may want to revisit supplier qualification and audit files for CGMP compliance.
  • The recall is open and nationwide, so scope or status could change; the FDA enforcement report is the place to watch.
  • The commercial impact is unquantified: no volumes, lots or financial details are given.

Official record: FDA enforcement report ↗

Written by CompePharma's editorial system from the official record. AI-assisted; check the source before acting. Not investment advice.

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