CLASS II ONGOING Drug recall · Reported 2 Jul 2025 · FDA Enforcement Report
Semaglutide, 5 mg/mL, pre-filled syringe recalled
Thrive Health and Wellness, LLC is recalling Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, 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-0479-2025
- 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
- Foreign Material
- 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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Semaglutide, 2.5 mg/mL, 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
Is Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E recalled?
Yes. Thrive Health and Wellness, LLC recalled Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E on 21 May 2025. The recall is Class II and its status is Ongoing. Recall number D-0479-2025.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: H270221, Exp 12/26/2025
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Foreign Material | Nationwide |
| Drug | CLASS II | Tirzepatide Injections, 20mg/mL, pre-filled syringe recalled | Thrive Health and Wellness, LLC | Foreign Material | Nationwide |
| Drug | CLASS II | Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL recalled | Thrive Health and Wellness, LLC | Foreign Material | Nationwide |
| Drug | CLASS II | LL Bioboost Injectable, Each contains Methionine 25 mg recalled | Thrive Health and Wellness, LLC | Foreign Material | Nationwide |
| Drug | CLASS II | LX Bioboost Plus, (Each contains Methionine 25 mg recalled | Thrive Health and Wellness, LLC | Foreign Material | Nationwide |