Methotrexate Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Methotrexate, USP, Sterile Solution for Injection (125 mg/5mL) due to lack of assurance of sterility. The recall affects 457 syringes distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable medication with lack of assurance of sterility, which creates a risk of serious harm (infections from non-sterile injection). The source text does not report any actual illnesses or injuries, making this a theoretical risk-of-harm scenario. Per the rubric, such cases score at most 3 (High).
Plain-English summary
Edge Pharma, LLC is recalling Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2 mg/mL), 5 mL per syringe, NDC 05446-1505-05, due to lack of assurance of sterility.
The affected product consists of 457 syringes with lot numbers 09-2021-10@2 (dated 12/23/2021), 10-2021-21@2 (dated 02/01/2022), and 11-2021-09@5 (dated 02/21/2022). The product was distributed nationwide.
Methotrexate is an injectable medication, and use of a non-sterile product could result in serious infections. Patients who received this product should contact their healthcare provider immediately if they experience signs of infection.
The FDA is investigating this recall. Customers with questions may contact Edge Pharma, LLC at 856 Hercules Drive, Colchester, Vermont 05446.
The recalled product
- Product
- Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Sterile Injectable
- Affected units
- 457
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 09-2021-10@2 12/23/2021
- 10-2021-21@2 02/01/2022 & 11-2021-09@5 02/21/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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