FDA Drug recall D-0511-2024
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…
- FDA Drug
- Class I
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class I recall of 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… by Revive Rx, citing labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0511-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-04-20 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Revive Rx |
| Distribution | US |
Product
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
Reason
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Identifiers
| code_info | Lot #: 748127, Exp 9/24/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0511-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.