Methotrexate Sodium Injection Shortage: Current Availability and Manufacturer Updates
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The FDA reports an ongoing shortage of Methotrexate Sodium Injection, a critical medication for oncology and rheumatology, due to active ingredient supply issues.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Drug Shortages — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Methotrexate Sodium) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What's in Shortage
Methotrexate Sodium Injection (Brand Name: METHOTREXATE) is currently listed in shortage by the FDA. This medication, available in various injection presentations, is primarily used within the therapeutic categories of Oncology and Rheumatology. The shortage status is currently active.
Which Manufacturers Are Affected
Several manufacturers are involved in the supply of Methotrexate Sodium Injection, with varying levels of availability:
Accord Healthcare Inc.
- Status: Unavailable
- Products: Preservative Free, 25 mg/1 mL (NDC 16729-277-30 and 16729-277-35)
- Contact: 866-941-7875, option 2
Fresenius Kabi USA, LLC
- Status: Available
- Products: 25 mg/1 mL (NDC 63323-123-10) and Preservative Free, 1 g (NDC 63323-122-50)
- Notes: Patients and providers are advised to check wholesalers for current inventory.
- Contact: 888-386-1300
Teva Pharmaceuticals USA, Inc.
- Status: Available
- Products: Preservative Free, 25 mg/1 mL (NDC 0703-3678-01, 0703-3675-01, and 0703-3671-01)
- Contact: 800-545-8800
Why There's a Shortage
According to the FDA database, the primary reason for this shortage is a shortage of an active ingredient required to manufacture the medication.
What Patients Should Do
If you rely on Methotrexate Sodium Injection for your treatment, please consider the following steps:
- Consult Your Healthcare Provider: Speak with your doctor or specialist immediately to discuss your treatment plan and ensure continuity of care.
- Talk to Your Pharmacist: Pharmacists may have the most up-to-date information on local stock or may be able to source the medication from different wholesalers.
- Contact Manufacturers: You may use the contact information provided above to inquire about specific supply timelines for your region.
Disclaimer: Patients should always consult their healthcare provider before making any changes to their medication or treatment regimen.
Source
Information provided by the FDA Drug Shortage Database.
Initial Posting Date: 03/13/2023
Last Updated: 02/03/2026
Original source: FDA Official Notice ↗
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