CLASS II Drug recall · Reported 2 Jun 2021 · FDA Enforcement Report
Methotrexate Injection, USP 50 mg recalled by Cardinal Health
Cardinal Health is recalling Methotrexate Injection, USP 50 mg/ (25 mg/mL) 5 x Single-Dose Vials, Sterile, distributed in Florida, Georgia, South Carolina. The recall was initiated on 15 Mar 2021 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-0553-2021
- FDA event ID
- 87512
- Recalling firm
- Cardinal Health, Dublin, OH
- Brand
- Methotrexate
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2021
- FDA classified
- 24 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Mar 2021 | Recall initiated by company | |
| 24 May 2021 | Classified by FDA | +70 days |
| 2 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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 Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.
Where it was distributed
FL, GA, SC
Questions about this recall
Is Methotrexate Injection, USP 50 mg/ (25 mg/mL) 5 x Single-Dose Vials, Sterile recalled?
Yes. Cardinal Health recalled Methotrexate Injection, USP 50 mg/ (25 mg/mL) 5 x Single-Dose Vials, Sterile on 15 Mar 2021. The recall is Class II and its status is Terminated. Recall number D-0553-2021.
Why was it recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which lots are affected?
H074437AA
Where was it sold?
FL, GA, SC
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 Cardinal Health
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|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |
Other Methotrexate recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methotrexate Tablets, USP, 5mg recalled by Amneal Pharmaceuticals | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Methotrexate Tablets, USP, 5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS I | Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial recalled | Mylan Institutional | Particulate Matter | Nationwide |
| Drug | CLASS II | Methotrexate USP active pharmaceutical ingredient recalled | Attix Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS I | Methotrexate Injection, USP, Preservative-Free recalled | Sandoz Incorporated | Particulate Matter | Nationwide |