Edge Pharma, LLC recalls Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only,
Edge Pharma recalls Methotrexate injection due to expired sterility testing media. This could lead to contamination. Check product details and contact customer service for action.
Recall notice
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Contact the company & request your remedy
What happened, in plain English
Edge Pharma is recalling Methotrexate injection products because the sterility testing media used was expired. This could cause contamination and infection if the medication is used. Affected patients should stop using the product and contact their healthcare provider. Read more at govinfonow.com/recall/37295-edge-pharma-methotrexate-injection-recall-expired-sterility-test-media-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37295-edge-pharma-methotrexate-injection-recall-expired-sterility-test-media-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0226-2021
Cite this page
“Edge Pharma Methotrexate Injection Recall: Expired Sterility Test Media Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37295-edge-pharma-methotrexate-injection-recall-expired-sterility-test-media-risk. Based on FDA recall #D-0226-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0226-2021%22&limit=1).
Why it’s dangerous
The sterility testing media used to check for contamination was expired. This means the product might not be sterile when compounded, increasing the risk of infection if injected.
Who’s affected
Patients prescribed Methotrexate injections by a doctor are affected. Those using the recalled product without medical supervision are at risk of infection.
How to tell if you have this one
Check for the product name 'Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only'. The lot number starts with 01-2020-28@10.
- Brand
Edge Pharma- Product
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only- Category
Drug
What to do — step by step
Stop Using Product
Immediately stop using the recalled Methotrexate injection product if you have it.
Questions people ask
Is this product safe to use?
No, the product is recalled due to expired sterility testing media, which could lead to contamination.
How do I check if my product is recalled?
Check the lot number on the product label; recalled products have lot numbers starting with 01-2020-28@10.
What should I do if I have the recalled product?
Contact Edge Pharma customer service at 1-802-992-1178 to get instructions on disposal or replacement.
Contact Edge Pharma
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0226-2021 — Edge Pharma Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml) Hello, I own a Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only that is covered by recall D-0226-2021 from Edge Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0226-2021 (March 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0226-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.