Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Sub-potent Drug
Cause type: Other
Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics. All other recalls.
What was recalled
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
Affected NDC
99000-9278-64
Compare with the code on your package — it is the most precise check available.
Drug: Tirzepatide
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0771-2023 · 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 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.
Other recalls by Revive Rx LLC dba Revive Rx Pharmacy
All 2023 recalls
Class I · High risk
Tirzepatide 10 mg/0.5 mL Sterile Solution
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class I · High risk
Hcg 6
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
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