Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Tirzepatide Inj
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Affected NDC
84223-0002-04
Compare with the code on your package — it is the most precise check available.
Drug: Tirzepatide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tirzepatide NDC 84223-0002 |
1 mg/mg | Powder | Nomida LLC | BULK INGREDIENT |
- Recalling firm
- New Life Pharma LLC
- NDC code
- 84223-002-04
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0395-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Tirzepatide recalls
See all
Class II · Moderate risk
Tirzepatide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Other recalls by New Life Pharma LLC
All 2026 recalls
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Inj
Lack of Assurance of Sterility
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.