Class II · Moderate risk
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Tirzepatide/Niacinamide 2mL vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Drug: Niacinamide
- Recalling firm
- Houston Rx LLC
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0040-2027 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Niacinamide recalls
See all
Class II · Moderate risk
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Other recalls by Houston Rx LLC
All 2026 recalls
Class II · Moderate risk
Sermorelin
Lack of process control
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