Ketorolac Tromethamine Injection Shortage: Current Availability and Manufacturer Updates

Source: FDA · United States

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Supply of Ketorolac Tromethamine Injection is currently limited, with mixed availability reported across several major pharmaceutical manufacturers.

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, Ketorolac Tromethamine) 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

Ketorolac Tromethamine Injection (Brand Name: KETOROLAC TROMETHAMINE) is currently listed as in shortage. This medication is used within the Analgesia/Addiction therapeutic category. The shortage affects various strengths and presentations of the injection form. This shortage was first posted on March 26, 2018, and was last updated on February 3, 2026.

Which Manufacturers Are Affected

Availability varies significantly by manufacturer and specific product presentation:

  • Sagent Pharmaceuticals (866-625-1618):

    • 30 mg/1 mL (NDC 25021-701-01): Available
    • 15 mg/1 mL (NDC 25021-700-01): Available
    • 30 mg/1 mL (NDC 25021-701-02): Available
  • Baxter Healthcare (888-229-0001):

    • 30 mg/1 mL (NDC 0338-0072-25): Available
    • 15 mg/1 mL (NDC 0338-0069-10): Available
  • Fresenius Kabi USA, LLC (888-386-1300):

    • 15 mg/1 mL (NDC 63323-161-01): Available (Check wholesaler inventory)
    • 30 mg/1 mL (NDC 63323-162-02): Available (Check wholesaler inventory)
    • 30 mg/1 mL (NDC 76045-104-10): Unavailable
    • 60 mg/2 mL (NDC 76045-105-20): Unavailable
    • 15 mg/1 mL (NDC 76045-107-10): Unavailable
    • 30 mg/1 mL (NDC 63323-162-01): Unavailable; next release date not available.

Why There's a Shortage

No specific reason for the shortage was provided in the current FDA report.

What Patients Should Do

If you are a patient who requires Ketorolac Tromethamine Injection, please consider the following steps:

  • Consult your healthcare provider: Discuss your treatment plan and any concerns regarding medication availability.
  • Speak with your pharmacist: They can check current wholesaler inventory and may have information on which specific presentations are in stock.
  • Contact manufacturers: You may use the contact numbers provided above to inquire about the most recent availability status for specific NDC numbers.

Disclaimer: This article is for informational purposes only. Patients should always consult with their healthcare provider or pharmacist for medical advice and guidance regarding medication changes or alternatives.

Source

Information provided by the FDA Drug Shortage Database.

Original source: FDA Official Notice ↗

All Drug Shortages →

Frequently Asked Questions

Common questions about this FDA drug-shortage notice.

What is this FDA drug-shortage notice about?
Supply of Ketorolac Tromethamine Injection is currently limited, with mixed availability reported across several major pharmaceutical manufacturers.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more Drug Shortages updates?
Browse the full Drug Shortages feed on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.