Houston Rx Llc: Tirzepatide/niacinamide

Recall Summary Houston Rx LLC is recalling Tirzepatide/Niacinamide injectable vials (20mg/2mg per 2mL dose) distributed nationwide because the company cannot confirm the product was manufactured under sterile conditions. The affected vials were distributed across all U.S. states and Washington, D.C. This is classified as a Class II recall, meaning use of the product could cause serious adverse health effects or death.

Recalling firm
Houston Rx LLC
Product
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.
Reason
Lack of assurance of sterility.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-09-25
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/4444e207-d22a-41dd-978a-84d35a9ce158