CLASS I Drug recall · Reported 19 Aug 2015 · FDA Enforcement Report
Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial recalled
Mylan Institutional is recalling Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial, distributed nationwide in the US. The recall was initiated on 18 Mar 2015 and the FDA has classified it as Class I.
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-1328-2015
- FDA event ID
- 70936
- Recalling firm
- Mylan Institutional, Rockford, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Mar 2015
- FDA classified
- 13 Aug 2015
- Reported
- 19 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Mar 2015 | Recall initiated by company | |
| 13 Aug 2015 | Classified by FDA | +148 days |
| 19 Aug 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter
Product as listed by the FDA
Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial recalled?
Yes. Mylan Institutional recalled Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial on 18 Mar 2015. The recall is Class I and its status is Terminated. Recall number D-1328-2015.
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot #: a) 7801082, Exp. 07/15 and b) 7801421, Exp. 09/16
Where was it sold?
Nationwide and Puerto Rico
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg 15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg 125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets recalled by Mylan InstitutionalLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets recalled by Mylan InstitutionalLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets recalled by Mylan InstitutionalLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
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 II | Methotrexate Injection, USP 50 mg recalled by Cardinal HealthMethotrexate | Cardinal Health | Sterility | FL, GA, SC |
| 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 |