CLASS II Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
Methotrexate 25mg/mL Injectable vials recalled by The Compounding Shop
The Compounding Shop is recalling Methotrexate 25mg/mL Injectable vials, Compounded by The Compounding Shop, St. Petersburg, distributed in California, Florida, Maine, Minnesota. The recall was initiated on 2 May 2013 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-548-2013
- FDA event ID
- 65125
- Recalling firm
- The Compounding Shop, St Petersburg, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2013
- FDA classified
- 4 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 May 2013 | Recall initiated by company | |
| 4 Jun 2013 | Classified by FDA | +33 days |
| 12 Jun 2013 | 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: FDA inspection findings resulted in concerns regarding quality control processes.
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 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Where it was distributed
Florida, California, Minnesota, and Maine
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Which lots are affected?
All Lots
Where was it sold?
Florida, California, Minnesota, and Maine
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
24 other products · FDA event 65125This product is part of a recall event; the main page for the event is Morphine Sulfate 25 mg/mL Injectable vial recalled.
More recalls from The Compounding Shop
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tri-Mix Injections in and vials (Alprostadil recalled | The Compounding Shop | Sterility | 4 states |
| Drug | CLASS II | MIC (Methionine, Inositol, and Choline) Injectable vials recalled | The Compounding Shop | Sterility | 4 states |
| Drug | CLASS II | Carnosine 5% Opth drop vial recalled by The Compounding Shop | The Compounding Shop | Sterility | 4 states |
| Drug | CLASS II | Hydroxyprogesterone 250 mg/mL Injectable and vials recalled | The Compounding Shop | Sterility | 4 states |
| Drug | CLASS II | MIC (Methionine, Inositol, and Choline) + B12 recalled | The Compounding Shop | Sterility | 4 states |
Other Methotrexate recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methotrexate Tablets, USP, 2.5mg recalled by Amneal Pharmaceuticals | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Methotrexate Tablets, USP, 2.5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS II | Methotrexate, USP, Sterile Solution for Injection (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Methotrexate Injection, USP 50 mg recalled by Cardinal HealthMethotrexate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Methotrexate, USP Sterile Solution for Injection recalled by Edge Pharma | Edge Pharma | Sterility | Nationwide |