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Class II: temporary or reversible health riskOngoing

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) Tirzepatide/Cyanocobalamin Injectable Recall

Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Englewood, CO

Risk level
Class II
Reported by FDA
Jul 2, 2025
Recall ID
D-0486-2025
Check your lot numberHow we source this data

Summary

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalled Tirzepatide/Cyanocobalamin Injectable starting May 21, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0486-2025 on Jul 2, 2025. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

Product description

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

Lot numbers, UPCs & expiration codes

Lot: C03125A

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0486-2025
Classification
Class II
Status
Ongoing
Recall initiated
May 21, 2025
FDA report date
Jul 2, 2025
Quantity
242 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Original FDA data

Every field from FDA enforcement report D-0486-2025, exactly as published.

Show all FDA fields
City
Englewood
State
CO
Status
Ongoing
Country
United States
Event ID
96742
Address
88 Inverness Cir E Unit A204
Code information
Lot: C03125A
Postal code
80112-5521
Report date
Jul 2, 2025
Product type
Drugs
Recall number
D-0486-2025
Classification
Class II
Recalling firm
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Product quantity
242 syringes
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
USA Nationwide
Recall initiation date
May 21, 2025
Initial firm notification
E-Mail
Center classification date
Jun 20, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0486-2025, published Jul 2, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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