Tirzepatide 10 mg/0.5 mL Sterile Solution recall
FDA recall D-0511-2024 · initiated Apr 20, 2024
Revive Rx LLC dba Revive Rx Pharmacy recalled Tirzepatide 10 mg/0.5 mL Sterile Solution in Apr 2024 — an FDA Class I recall (D-0511-2024) because Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 751 vials
Details
- 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
- Recalling company
- Revive Rx LLC dba Revive Rx Pharmacy
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Apr 20, 2024
- FDA report date
- Jun 5, 2024
Frequently asked
- Was Tirzepatide 10 mg/0.5 mL Sterile Solution recalled?
- Revive Rx LLC dba Revive Rx Pharmacy recalled Tirzepatide 10 mg/0.5 mL Sterile Solution in Apr 2024 — an FDA Class I recall (D-0511-2024) because Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Tirzepatide 10 mg/0.5 mL Sterile Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0511-2024 was: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
- Is a recalled Tirzepatide 10 mg/0.5 mL Sterile Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tirzepatide 10 mg/0.5 mL Sterile Solution are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 748127, Exp 9/24/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0511-2024.