Tirzepatide/Niacinamide 2mL vial recall (Houston Rx LLC)
DrugClass IIOngoing
Summary: Houston Rx LLC is recalling 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.
What is being 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.
Why
Lack of assurance of sterility.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0040-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 25, 2026 |
| Reported | October 21, 2026 |
| Company | Houston Rx LLC |
| Company location | Houston, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 64 vials |
More recalls from Houston Rx LLC · all drug recalls · recalls from September 2026