CLASS II Drug recall · Reported 20 Jan 2021 · FDA Enforcement Report
Methotrexate, USP Sterile Solution for Injection recalled by Edge Pharma
Edge Pharma is recalling Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/ (25mg/ml) per, distributed nationwide in the US. The recall was initiated on 19 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0226-2021
- FDA event ID
- 87115
- Recalling firm
- Edge Pharma, Colchester, VT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2020
- FDA classified
- 12 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Mar 2020 | Recall initiated by company | |
| 12 Jan 2021 | Classified by FDA | +299 days |
| 20 Jan 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
Where it was distributed
Nationwide
Questions about this recall
Is Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/ (25mg/ml) per recalled?
Yes. Edge Pharma recalled Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/ (25mg/ml) per on 19 Mar 2020. The recall is Class II and its status is Terminated. Recall number D-0226-2021.
Why was it recalled?
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Which lots are affected?
Lot# 01-2020-28@10
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Edge Pharma
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl, Sterile Solution for Injection, (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Tetracaine HCl Nasal Solution recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Methotrexate, USP, Sterile Solution for Injection (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | CSF Otic Insufflation Capsule recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ceftazidime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |