CLASS I ONGOING Drug recall · Reported 5 Jun 2024 · FDA Enforcement Report
Tirzepatide 10 mg/ Sterile Solution Multi-dose vial recalled
Revive Rx is recalling Tirzepatide 10 mg/ Sterile Solution Multi-dose vial, distributed nationwide in the US. The recall was initiated on 20 Apr 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0511-2024
- FDA event ID
- 94550
- Recalling firm
- Revive Rx, Houston, TX
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Apr 2024
- FDA classified
- 29 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 20 Apr 2024 | Recall initiated by company | |
| 29 May 2024 | Classified by FDA | +39 days |
| 5 Jun 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Which lots are affected?
Lot #: 748127, Exp 9/24/2024
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Revive Rx
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirzepatide 10 mg/ Sterile Solution- Vial recalled by Revive Rx | Revive Rx | Other | Nationwide |
| Drug | CLASS I | HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj. recalled | Revive Rx | Sterility | Nationwide |
Other Tirzepatide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirzepatide Injection, 27 mg/ (9 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Tirzepatide, 60mg/ for Injection vial lyophilized recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide 20 mg/ (10/mg/mL) recalled by ProRx | ProRx | Sterility | Nationwide |