Morphine Sulfate Injection Shortage: Updates on Availability and Manufacturer Status
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The FDA reports a current shortage of Morphine Sulfate Injection due to increased demand, with several presentations from Fresenius Kabi USA currently unavailable.
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, MorphineSulfate) 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
Morphine Sulfate Injection (Brand Name: MORPHINE SULFATE) is currently listed as in shortage. This medication is categorized under Analgesia/Addiction and is provided in an injection dosage form. The shortage status is currently active.
Which Manufacturers Are Affected
Fresenius Kabi USA, LLC is the manufacturer reported in the current database update. Availability varies significantly by specific presentation:
- Morphine Sulfate, Injection, 5 mg/1 mL (NDC 63323-455-01): Unavailable. Not available at this time.
- Morphine Sulfate, Injection, 4 mg/1 mL (NDC 76045-005-11): Available. Check wholesalers for inventory.
- Morphine Sulfate, Injection, 2 mg/1 mL (NDC 63323-452-01): Unavailable. Next release not available at this time. Check wholesalers for inventory.
- Morphine Sulfate, Injection, 2 mg/1 mL (NDC 76045-004-11): Unavailable. Next release expected February 2026. Check wholesalers for inventory.
- Morphine Sulfate, Injection, 10 mg/1 mL (NDC 63323-451-01): Unavailable. Next release not available at this time.
- Morphine Sulfate, Injection, 4 mg/1 mL (NDC 63323-454-01): Available. Check wholesalers for inventory.
For more information, Fresenius Kabi USA, LLC can be contacted at 888-386-1300.
Why There's a Shortage
The FDA indicates that the primary reason for this shortage is a demand increase for the drug.
What Patients Should Do
If you are affected by this shortage, please take the following steps:
- Consult your healthcare provider: Discuss your treatment options and any concerns regarding the availability of your medication. Do not make any changes to your treatment plan without medical supervision.
- Talk to your pharmacist: Pharmacists often have the most up-to-date information regarding local stock and can check with various wholesalers.
- Contact the manufacturer: You may use the contact information provided above to inquire about supply timelines.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should always consult with their healthcare provider for medical guidance.
Source
Attribution: FDA Drug Shortage Database Initial Posting Date: 10/31/2017 Last Updated: 02/05/2026
Original source: FDA Official Notice ↗
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