Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL recall
FDA recall D-0651-2024 · initiated Aug 22, 2024
ProRx LLC recalled Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL in Aug 2024 — an FDA Class II recall (D-0651-2024) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
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: 37 vials
Details
- Product
- Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
- Recalling company
- ProRx LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 22, 2024
- FDA report date
- Sep 11, 2024
Frequently asked
- Was Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL recalled?
- ProRx LLC recalled Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL in Aug 2024 — an FDA Class II recall (D-0651-2024) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL recalled?
- Per the FDA enforcement record, the reason for recall D-0651-2024 was: Lack of Assurance of Sterility
- Is a recalled Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 2 mL (10 mg/mL) and 20 mg/mL are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # ProRx040924-1, BUD 10/08/2024. 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-0651-2024.