Hydromorphone Hydrochloride Injection (Dilaudid) Shortage: Availability Updates and Manufacturer Status
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The FDA has updated the shortage status for Hydromorphone Hydrochloride Injection, noting that while some strengths remain available, several presentations are currently backordered.
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, Hydromorphone) 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
Hydromorphone Hydrochloride Injection, also known by the brand name Dilaudid, is currently listed in a shortage status by the FDA. This medication belongs to the Analgesia/Addiction therapeutic category and is provided in an injection dosage form. The shortage was first posted on November 1, 2017, and was most recently updated on February 5, 2026.
Which Manufacturers Are Affected
The following manufacturers have reported varying levels of availability for Hydromorphone Hydrochloride Injection:
Fresenius Kabi USA, LLC
Contact: 888-386-1300
- Available:
- Dilaudid, Injection, .2 mg/1 mL (NDC 76045-121-11) — Note: Check wholesalers for inventory.
- Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-50) — Note: Check wholesalers for inventory.
- Unavailable:
- Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-852-25) — Next release expected March 2026.
- Dilaudid, Injection, 1 mg/1 mL (NDCs 76045-009-11, 76045-009-06) — Next release expected February 2026.
- Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 63323-853-25) — Next release not available at this time.
- Dilaudid, Injection, 2 mg/1 mL (NDC 76045-010-11) — Next release not available at this time.
- Hydromorphone Hydrochloride, Injection, 4 mg/1 mL (NDC 63323-854-10) — Next release not available at this time.
- Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDCs 63323-851-10, 63323-851-15) — Next release not available at this time.
Teva Pharmaceuticals USA, Inc.
Contact: 800-545-8800
- Available:
- Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDCs 0703-0018-01, 0703-0110-03, 0703-0113-03).
Why There's a Shortage
The FDA source data does not provide a specific reason for the current shortage of Hydromorphone Hydrochloride Injection.
What Patients Should Do
Patients who rely on this medication should be aware that while some concentrations are unavailable, others remain in supply. If you are affected by this shortage:
- Consult with your healthcare provider or pharmacist regarding your treatment plan.
- Ask your pharmacist to check with various wholesalers for existing inventory.
- Contact the manufacturers directly using the phone numbers provided above for the most recent updates on specific product availability.
Disclaimer: Patients should always consult their healthcare provider for medical advice and treatment options.
Source
Information provided by the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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