Hydromorphone Hydrochloride Injection (Dilaudid) Shortage: Availability Updates and Manufacturer Status

Drug Shortages medium FDA · · United States

The FDA has updated the shortage status for Hydromorphone Hydrochloride Injection, noting that while some strengths remain available, several presentations are currently backordered.

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.