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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Revive Rx Tirzepatide Recalled for Containing Testosterone Cypionate

Agency Publication Date: May 29, 2024
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Summary

Revive Rx Pharmacy is recalling 751 vials of Tirzepatide 10 mg/0.5 mL sterile solution because of a labeling mix-up. The product, which is a compounded weight-loss and diabetes medication, actually contains testosterone cypionate. The recalled medication was sold in 2 mL multi-dose vials and distributed nationwide.

Risk

Patients expecting tirzepatide will instead receive testosterone, which can cause significant hormonal imbalances and adverse health effects. Using the incorrect medication may lead to unintended physical changes and complications that require medical attention.

What You Should Do

  1. The recalled product is Tirzepatide 10 mg/0.5 mL Sterile Solution, packaged in 2 mL multi-dose vials, with lot number 748127 and expiration date 9/24/2024.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tirzepatide Sterile Solution (2 mL)
Variants: 10 mg/0.5 mL, Multi-dose vial
Lot Numbers:
748127 (Exp 9/24/2024)
NDC:
99000-9278-64

Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94550
Status: Active
Manufacturer: Revive Rx LLC dba Revive Rx Pharmacy
Sold By: Revive Rx Pharmacy
Manufactured In: United States
Units Affected: 751 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.