CLASS II ONGOING Drug recall · Reported 31 May 2023 · FDA Enforcement Report
Tirzepatide 10 mg/ Sterile Solution- Vial recalled by Revive Rx
Revive Rx is recalling Tirzepatide 10 mg/ Sterile Solution- Vial, distributed nationwide in the US. The recall was initiated on 11 May 2023 and the FDA has classified it as Class II.
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-0771-2023
- FDA event ID
- 92329
- Recalling firm
- Revive Rx, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 May 2023
- FDA classified
- 25 May 2023
- Reported
- 31 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 11 May 2023 | Recall initiated by company | |
| 25 May 2023 | Classified by FDA | +14 days |
| 31 May 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potent Drug
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US
Questions about this recall
Is Tirzepatide 10 mg/ Sterile Solution- Vial recalled?
Yes. Revive Rx recalled Tirzepatide 10 mg/ Sterile Solution- Vial on 11 May 2023. The recall is Class II and its status is Ongoing. Recall number D-0771-2023.
Why was it recalled?
Sub-potent Drug
Which lots are affected?
Lot: 1643397 BUD: 10/16/2023
Where was it sold?
Nationwide in the US
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 I | Tirzepatide 10 mg/ Sterile Solution Multi-dose vial recalled | Revive Rx | Sterility | Nationwide |
| Drug | CLASS I | HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj. recalled | Revive Rx | Sterility | Nationwide |