Quality & complianceOfficial

FDA classifies Houston Rx's sermorelin recall as Class II over lack of process control

🇺🇸 FDA enforcement report · Wed 21 Oct 2026

The nationwide US recall of sermorelin from Houston Rx LLC, numbered D-0041-2027, is listed as ongoing in the FDA's enforcement report dated 21 October 2026.

The US Food and Drug Administration has listed a Class II drug recall of sermorelin from Houston Rx LLC in its enforcement report dated 21 October 2026. The recall carries the number D-0041-2027.

The stated reason for the recall is lack of process control. The entry on file gives no further detail on the nature of the process failure, the affected lots, the quantities involved or the strength and presentation of the product.

The recall status is shown as ongoing, meaning the action had not been closed at the time of the report. Distribution is listed as nationwide in the USA.

The page text supplied consists mostly of search-tool navigation and help instructions for the FDA's enforcement report database. It does not include the full product description, code information or event ID. Readers who need those details should consult the full record in the FDA database.

As context, the FDA defines a Class II recall as one involving a product that 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

  • Distributors, pharmacies and clinics that handle sermorelin from Houston Rx should check the full FDA record for lot and code information and review their stock.
  • Quality teams can treat the 'lack of process control' wording as a reminder to review process-control and batch-record oversight, particularly for compounded or outsourced products.
  • Pharmacovigilance and compliance staff should note that the recall is ongoing and nationwide, and watch for any update to its status.

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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