FDA-Drug2026-10-21Class IIPROCESSING DEFECT
Houston Rx LLC Tirzepatide/Niacinamide injection recalled for lack of sterility assurance
What this means
Houston Rx LLC has recalled a specific lot of Tirzepatide/Niacinamide injectable medication due to concerns that the sterility of the product cannot be assured. The affected lot (TZN-080326-20/2-2) contains 64 vials distributed nationwide. No injuries have been reported.
- If you have received this medication, do not use it.
- Contact your healthcare provider or pharmacy immediately to confirm whether you have the recalled lot.
- Return the medication to your pharmacy or healthcare provider for proper disposal.
The agency's original wording
Hazard
Lack of assurance of sterility.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA.
Affected count
64 vials
Manufactured in
15340 Vantage Pkwy E Ste 220, Houston, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0040-2027More Houston Rx recalls
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