# FDA recall D-0226-2021

> **Edge Pharma, LLC** · Class II · drug recall initiated 2020-03-19.

## Product

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

## Reason for recall

Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0226-2021
- **Recalling firm:** Edge Pharma, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-19
- **Report date:** 2021-01-20
- **Termination date:** 2023-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colchester, VT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2021

## Citation

> AI Analytics. FDA recall D-0226-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0226-2021. Source: US FDA. Licensed CC0.

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