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Home › FDA recalls › Tirzepatide/Niacinamide 2mL vial
CLASS II · ModerateFDA

Houston Rx LLC recalls Tirzepatide/Niacinamide 2mL vial

📅 Sep 25, 2026 · 📍 Nationwide
Recalling company
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 – may cause temporary or medically reversible health consequences
Recall date
Sep 25, 2026
Reported
Oct 21, 2026
Distribution
Nationwide in the USA.
Status
Ongoing
Quantity
64 vials
Lot / codes
Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.
Company location
Houston, TX
Recall type
Voluntary: Firm initiated
Recall number
D-0040-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0040-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.