Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Tirzepatide Injection
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 Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
Affected NDC
84139-0209-03
Compare with the code on your package — it is the most precise check available.
Drug: Tirzepatide
- Recalling firm
- ProRx LLC
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0120-2026 · 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 Inj
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 ProRx LLC
All 2025 recalls
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
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