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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 HCG Injection Recalled for Bacterial Contamination

Agency Publication Date: February 17, 2022
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Summary

Revive Rx LLC is recalling 115 vials of its HCG 6,000iu (lyo) Human Chorionic Gonadotropin Injection. This compounded medication, intended for subcutaneous or intramuscular injection, was found to have bacterial contamination. No injuries or incidents have been reported to date, but the manufacturer has voluntarily initiated this recall to protect patient safety.

Risk

The product is contaminated with the bacteria Paenibacillus lautus. Injecting a non-sterile drug can lead to serious, potentially life-threatening infections at the site of injection or in the bloodstream.

What You Should Do

  1. This recall affects HCG 6,000iu (lyo) Human Chorionic Gonadotropin Injection compounded by Revive Rx (NDC 88888-1739-01) from lot number 631359 with a Beyond Use Date (BUD) of 05/01/2022.
  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: HCG 6,000iu (lyo) Human Chorionic Gonadotropin Injection
Variants: 6,000iu, Lyophilized Powder, For Sub-Q or IM Use Only
Lot Numbers:
631359 (BUD: 05/01/2022)
NDC:
88888-1739-01

Compounded by Revive Rx at 3831 Golf Dr., Houston, TX 77018. Recall #: D-0648-2022.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89591
Status: Resolved
Manufacturer: Revive Rx LLC dba Revive Rx Pharmacy
Sold By: Revive Rx Pharmacy
Manufactured In: United States
Units Affected: 115 vials
Distributed To: Nationwide
Agency Last Updated: March 8, 2022

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.