Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Tirzepatide 10 mg/0.5 mL Sterile Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned 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
- NDC code
- 99000-9278-64
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0511-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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 2024 recalls
Class II · Moderate risk
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Sub-potent Drug
Class I · High risk
Hcg 6
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
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