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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

Edge Pharma, LLC: Methotrexate Injection Recalled Due to Lack of Assurance of Sterility

Agency Publication Date: January 12, 2021
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Summary

Edge Pharma, LLC is recalling 71 syringes of Methotrexate, USP Sterile Solution for Injection (125mg/5ml). This recall was initiated because the media used to perform required sterility testing after the drug was compounded had expired, meaning the company cannot guarantee the product is free from contamination. Methotrexate is a prescription medication often used for serious conditions like cancer or rheumatoid arthritis, and a lack of sterility in an injectable drug can lead to life-threatening infections. These syringes were distributed nationwide across the United States.

Risk

If an injectable medication is not sterile, it can introduce bacteria or fungi directly into the bloodstream or muscle tissue, potentially causing severe systemic infections, sepsis, or localized abscesses.

What You Should Do

  1. Check your medication to see if it is Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml) in a 5 mL syringe.
  2. Locate the lot number on the syringe or packaging; specifically look for Lot# 01-2020-28@10 (Lots: 01-2020-28) and Barcode 0544650505.
  3. Immediately stop using any syringes matching this lot number and set them aside in a secure location.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and to obtain a replacement prescription from a different source.
  5. Return any unused product to the place of purchase for a refund and contact Edge Pharma, LLC at 1-802-992-1178 for further instructions regarding the return process.
  6. For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

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

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

Affected Products

Product: Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe
Model:
Barcode 0544650505
Recall #: D-0226-2021
Lot Numbers:
01-2020-28@10
01-2020-28

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87115
Status: Resolved
Manufacturer: Edge Pharma, LLC
Sold By: Edge Pharma, LLC
Manufactured In: United States
Units Affected: 71 syringes
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 · 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.