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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Hydromorphone Hydrochloride Injection
Status: Currently in Shortage
»Date first posted: 10/31/2017
»Therapeutic Categories: Analgesia/Addiction

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Fresenius Kabi USA, LLC (Revised 11/05/2025)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-852-25) Unavailable Next release November 2025. Check wholesalers for inventory. Other
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 63323-853-25) Available Check wholesalers for inventory. Other
Hydromorphone Hydrochloride, Injection, 4 mg/1 mL (NDC 63323-854-10) Unavailable Backordered. Next release not available at this time. Check wholesaler for inventory. Other
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-10) Unavailable Next release not available at this time. Check wholesalers for inventory. Demand increase for the drug
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-15) Unavailable Next release January 2026. Check wholesalers for inventory. Other
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-50) Unavailable Next release not available at this time. Check wholesalers for inventory. Other
Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-11) Unavailable Next release not available at this time. Check wholesalers for inventory. Other
Dilaudid, Injection, .2 mg/1 mL (NDC 76045-121-11) Unavailable Next release not available at this time. Check wholesalers for inventory. Other
Dilaudid, Injection, 2 mg/1 mL (NDC 76045-010-11) Available Check wholesalers for inventory
Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-06) Unavailable Next release November 2025. Check wholesalers for inventory. Other

Hikma Pharmaceuticals USA, Inc. (Revised 10/24/2025)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-0121-25) Available Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released.
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-6254-01) Available Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released.

Hospira, Inc., a Pfizer Company (Reverified 10/23/2025)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-3365-10) Available
Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 0409-1283-37) Unavailable Next Delivery: April 2026; Estimated Recovery: June 2026 Other
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-1312-36) Unavailable Next Delivery and Estimated Recovery: March 2026 Other
Hydromorphone Hydrochloride, Injection, 0.5 mg/0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-4264-01) Limited Availability Limited Supply Available. Next Delivery: October 2025; Estimated Recovery: June 2026 Other
Hydromorphone Hydrochloride, Injection, 0.25 mg/ 0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-1805-01) Available
Hydromorphone Hydrochloride, Injection, 1 mg/1 mL Syringes (NDC 0409-1283-31) Unavailable Next Delivery: October 2025; Estimated Recovery: June 2026 Demand increase for the drug
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL Syringes (NDC 0409-1312-30) Unavailable Next Delivery and Estimated Recovery: December 2025 Other
Hydromorphone Hydrochloride, Injection, 4 mg/1 mL Syringes (NDC 0409-1304-31) Available
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0409-2634-01) Available
Hydromorphone Hydrochloride, Injection, 50 mg/5 mL (10 mg/mL) (NDC 0409-2634-05) Available
Hydromorphone Hydrochloride, Injection, 500 mg/50 mL (10 mg/mL) (NDC 0409-2634-50) Available

Teva Pharmaceuticals USA, Inc. (Revised 11/06/2025)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0110-03) Available
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0113-03) Limited Availability Estimated availability: November 2025 Shortage of an active ingredient
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0018-01) Available
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