FDAFDA recall D-0040-2027 · Oct 21, 2026
Houston Rx LLC: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL recall
Recall found
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 for recall
Lack of assurance of sterility.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.
- Quantity
- 64 vials
- Distribution
- Nationwide in the USA.
- Recalling firm
- Houston Rx LLC, Houston, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-25
Source: openFDA enforcement record D-0040-2027 · search recall number D-0040-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.