CLASS II ONGOING Drug recall · Reported 2 Jul 2025 · FDA Enforcement Report
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL recalled
Thrive Health and Wellness, LLC is recalling Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/, pre-filled syringe, distributed nationwide in the US. The recall was initiated on 21 May 2025 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-0486-2025
- FDA event ID
- 96742
- Recalling firm
- Thrive Health and Wellness, LLC, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2025
- FDA classified
- 20 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 21 May 2025 | Recall initiated by company | |
| 20 Jun 2025 | Classified by FDA | +30 days |
| 2 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
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/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: C03125A
Where was it sold?
USA Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 96742This product is part of a recall event; the main page for the event is Semaglutide, 5 mg/mL, pre-filled syringe recalled.
More recalls from Thrive Health and Wellness, LLC
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide Injections, 20mg/mL, pre-filled syringe recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | LL Bioboost Injectable, Each contains Methionine 25 mg recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | LX Bioboost Plus, (Each contains Methionine 25 mg recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
Other Tirzepatide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirzepatide Injection, 27 mg/ (9 mg/mL) Multidose Vial recalled by ProRx | ProRx | Sterility | TX, UT |
| Drug | CLASS II | Tirzepatide, 60mg/ for Injection vial lyophilized recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide 20 mg/ (10/mg/mL) recalled by ProRx | ProRx | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide 60 mg/ (20/mg/mL) recalled by ProRx | ProRx | Sterility | Nationwide |