Tirzepatide recalls

The FDA has published 9 recalls involving Tirzepatide since 2023. The latest was reported on 5 Nov 2025. Most were for sterility. ProRx has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls9since 2023

Last 12 months1reported

Class I111% of total

Ongoing9latest 5 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 2 0Aug 0 1 1Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 11%Class II 8 89%Class III 0 0%

Why tirzepatide is recalled

Companies

By year

2025444%
2024444%
2023111%

Ongoing tirzepatide recalls

9 active

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS II	Tirzepatide Injection, 27 mg/ (9 mg/mL) Multidose Vial recalled by ProRx	ProRx	Sterility	TX, UT
15 Oct 2025Drug	CLASS II	Tirzepatide, 60mg/ for Injection vial lyophilized recalled by GenoGenix	GenoGenix	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL recalled	Thrive Health and Wellness, LLC	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL recalled	Thrive Health and Wellness, LLC	Sterility	Nationwide
11 Sep 2024Drug	CLASS II	Tirzepatide 20 mg/ (10/mg/mL) recalled by ProRx	ProRx	Sterility	Nationwide
11 Sep 2024Drug	CLASS II	Tirzepatide 60 mg/ (20/mg/mL) recalled by ProRx	ProRx	Sterility	Nationwide

All tirzepatide recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS II	Tirzepatide Injection, 27 mg/ (9 mg/mL) Multidose Vial recalled by ProRx	ProRx	Sterility	TX, UT
15 Oct 2025Drug	CLASS II	Tirzepatide, 60mg/ for Injection vial lyophilized recalled by GenoGenix	GenoGenix	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL recalled	Thrive Health and Wellness, LLC	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL recalled	Thrive Health and Wellness, LLC	Sterility	Nationwide
11 Sep 2024Drug	CLASS II	Tirzepatide 20 mg/ (10/mg/mL) recalled by ProRx	ProRx	Sterility	Nationwide
11 Sep 2024Drug	CLASS II	Tirzepatide 60 mg/ (20/mg/mL) recalled by ProRx	ProRx	Sterility	Nationwide
11 Sep 2024Drug	CLASS II	Tirzepatide (10 mg/mL) and 20 mg/mL Multidose SC Injection recalled	ProRx	Sterility	Nationwide
5 Jun 2024Drug	CLASS I	Tirzepatide 10 mg/ Sterile Solution Multi-dose vial recalled	Revive Rx	Packaging Defects	Nationwide
31 May 2023Drug	CLASS II	Tirzepatide 10 mg/ Sterile Solution- Vial recalled by Revive Rx	Revive Rx	Other	Nationwide

Should you stop taking Tirzepatide?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.