Quality & complianceOfficial

FDA lists Class II recall of Houston Rx tirzepatide/niacinamide injection over sterility assurance

🇺🇸 FDA enforcement report · Wed 21 Oct 2026

Houston Rx's tirzepatide and niacinamide 2 mL vials are being recalled nationwide in the US because sterility cannot be assured, and the recall is ongoing.

The US Food and Drug Administration has published a Class II recall in its enforcement report for a compounded-style injectable combining tirzepatide and niacinamide, supplied by Houston Rx LLC. The recall carries the number D-0040-2027 and the report is dated 21 October 2026.

The product is described as a 2 mL vial containing 40 mg per vial, with a strength listed as 20 mg/2 mg/mL. The stated reason for the recall is a lack of assurance of sterility.

The enforcement entry lists distribution as nationwide in the USA, and the recall status is ongoing. The text available does not give lot numbers, expiry dates, quantities, the date the recall began or any report of adverse events, so the scale and reach of the affected product cannot be assessed from this record.

Under FDA's classification system, a Class II recall covers products that may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Pharmacovigilance teams should check whether any adverse event reports involve injectable tirzepatide/niacinamide products from Houston Rx, particularly infection-related events.
  • Quality and supply-chain teams at distributors, pharmacies or clinics should check their inventory against recall D-0040-2027 and the full FDA enforcement entry for lot details.
  • Regulatory affairs staff should note that the entry is still ongoing, so its status or scope may change.

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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