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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

ProRx Semaglutide and Tirzepatide Injections Recalled for Sterility Concerns

Agency Publication Date: October 27, 2025
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Summary

ProRx LLC is recalling 38,853 vials of compounded Semaglutide and Tirzepatide injections because they may not be sterile. The recall includes various strengths and sizes of multidose vials distributed in Texas and Utah. A lack of sterility in an injectable medication can lead to serious infections at the injection site or throughout the body. Consumers should contact their healthcare provider or pharmacist regarding these medications and avoid using any remaining product.

Risk

The medications were produced without adequate assurance of sterility, which could allow bacteria or other contaminants to be present in the vials. Injecting a non-sterile product can cause localized infections, abscesses, or life-threatening systemic infections.

What You Should Do

  1. Check your medication vials for the product name 'Semaglutide Injection' or 'Tirzepatide Injection' and the manufacturer name 'ProRx'.
  2. Verify if your medication matches the affected lot numbers, such as PRORX050925-1, ProRx051425-5, or PRORX08062025-3. See the Affected Products section below for the full list of affected codes.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

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: Semaglutide Injection, 12.5mg/5mL (2.5 mg/mL), 5mL Multidose Vial
Variants: 2.5 mg/mL, 5mL Multidose Vial, Subcutaneous Injection
Lot Numbers:
Prorx04282025-3
NDC:
84139-225-09

Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341

Product: Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial
Variants: 2.5 mg/mL, 4mL Multidose Vial, Subcutaneous Injection
Lot Numbers:
PRORX050925-1 (BUD 11/04/2025)
ProRx051425-5 (BUD 11/10/2025)
ProRx051425-6 (BUD 11/10/2025)
NDC:
84139-225-04

Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341

Product: Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial
Variants: 2.5 mg/mL, 2.4mL Multidose Vial, Subcutaneous Injection
Lot Numbers:
Prorx051425-2
Prorx051425-3
Prorx051425-4
NDC:
84139-225-08

Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341

Product: Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial
Variants: 2.5 mg/mL, 3.2mL Multidose Vial, Subcutaneous Injection
Lot Numbers:
Prorx051525-1
Prorx051525-2
Prorx051525-3
Prorx051525-4
NDC:
84139-225-09

Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341

Product: Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial
Variants: 2.5 mg/mL, 1mL Multidose Vial, Subcutaneous Injection
Lot Numbers:
Prorx051525-5
NDC:
84139-225-06

Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341

Product: Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial
Variants: 2.5 mg/mL, 2mL Multidose Vial, Subcutaneous Injection
Lot Numbers:
PRORX052125-4
NDC:
84139-225-02

Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341

Product: Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial
Variants: 9 mg/mL, 3mL Multidose Vial, Subcutaneous Injection
Lot Numbers:
PRORX08062025-3
NDC:
84139-209-03

Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97808
Status: Active
Manufacturer: ProRx LLC
Sold By: Direct-to-consumer; Specialty pharmacies
Manufactured In: United States
Units Affected: 7 products (2,809 vials; 8,400 vials; 8,310 vials; 11,119 vials; 2,649 vials; 2,805 vials; 2,761 vials)
Distributed To: Texas, Utah

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.