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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Innoveix Pharmaceuticals Inc: Compounded Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: October 28, 2019
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Summary

Innoveix Pharmaceuticals Inc. is recalling 6,355 vials of various compounded injectable medications, including Chorionic Gonadotropin (hCG) and Sermorelin, because they lack assurance of sterility. These prescription medications are used for hormone treatments and were distributed nationwide across the United States. Using a medication that is intended to be sterile but is contaminated with bacteria or fungi can lead to serious, life-threatening infections.

Risk

Non-sterile injectable products can introduce bacteria or fungi directly into the body, which may cause severe local or systemic infections, such as sepsis or meningitis. No specific injuries have been reported to date, but the risk remains significant for any patient who has received these injections.

What You Should Do

  1. Check your medication vials for the following brand names and lot numbers: Lyophilized Chorionic Gonadotropin 11,000 USP Units (Lots INX 530, 535, 540, 545, 550, 555, 560, 565, 570, 575), Human Chorionic Gonadotropin 5,000 USP Units (Lots INX 910, 915), Human Chorionic Gonadotropin 5,500 USP Units (Lot INX 50), and Sermorelin w/ GHRP2 3 mg (Lots SER 925, 930, 935, 400, 405, 410).
  2. Immediately stop using any of the affected products and secure them in a safe place.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and for guidance on how to return the product for a refund.
  4. Return any unused or partially used vials to the pharmacy where you originally purchased them.
  5. Contact Innoveix Pharmaceuticals Inc. directly at 800-370-1910 for further instructions regarding the recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return products to the place of purchase.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection
Model:
Recall #: D-0157-2020
Lot Numbers:
INX 530 (Exp. 11/6/19)
INX 535 (Exp. 11/15/19)
INX 540 (Exp. 2/1/20)
INX 545 (Exp. 2/15/20)
INX 550 (Exp. 3/9/20)
INX 555 (Exp. 3/26/20)
INX 560 (Exp. 5/3/20)
INX 565 (Exp. 5/18/20)
INX 570 (Exp. 6/28/20)
INX 575 (Exp. 7/18/20)
Date Ranges: 11/6/19, 11/15/19, 2/1/20, 2/15/20, 3/9/20, 3/26/20, 5/3/20, 5/18/20, 6/28/20, 7/18/20
Product: Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection
Model:
Recall #: D-0158-2020
Lot Numbers:
INX 910 (Exp. 2/7/20)
INX 915 (Exp. 3/12/20)
Date Ranges: 2/7/20, 3/12/20
Product: Lyophilized Sermorelin w/ GHRP2 3 mg For injection
Model:
Recall #: D-0159-2020
Lot Numbers:
SER 925 (Exp. 11/4/19)
SER 930 (Exp. 11/18/19)
SER 935 (Exp. 2/21/20)
SER 400 (Exp. 4/1/20)
SER 405 (Exp. 5/11/20)
SER 410 (Exp. 7/15/20)
Date Ranges: 11/4/19, 11/18/19, 2/21/20, 4/1/20, 5/11/20, 7/15/20
Product: Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection
Model:
Recall #: D-0160-2020
Lot Numbers:
INX 50 (Exp. 5/1/20)
Date Ranges: 5/1/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84006
Status: Resolved
Manufacturer: Innoveix Pharmaceuticals Inc
Sold By: Direct from manufacturer; Healthcare providers; Pharmacies
Manufactured In: United States
Units Affected: 4 products (3905 vials; 413 vials; 1747 vials; 290 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.