Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Morphine Sulfate Injection
Status: Currently in Shortage
»Date first posted:
10/31/2017
»Therapeutic Categories: Analgesia/Addiction
Amphastar Pharmaceuticals, Inc. (Reverified 04/09/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Morphine Sulfate, Injection, 1 mg/1 mL (NDC 76329-1912-1) | Available |
Fresenius Kabi USA, LLC (Revised 04/24/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Morphine Sulfate, Injection, 2 mg/1 mL (NDC 63323-452-01) | Unavailable | Backordered. Next release May 2025. Check wholesaler for inventory. | Demand increase for the drug |
| Morphine Sulfate, Injection, 4 mg/1 mL (NDC 63323-454-01) | Unavailable | Backordered. Next release May 2025. Check wholesaler for inventory. | Demand increase for the drug |
| Morphine Sulfate, Injection, 5 mg/1 mL (NDC 63323-455-01) | Unavailable | Not available at this time. | Demand increase for the drug |
| Morphine Sulfate, Injection, 10 mg/1 mL (NDC 63323-451-01) | Unavailable | Backordered. Next release May 2025. Check wholesaler for inventory. | Demand increase for the drug |
| Morphine Sulfate, Injection, 2 mg/1 mL (NDC 76045-004-11) | Available | Check wholesalers for inventory | |
| Morphine Sulfate, Injection, 4 mg/1 mL (NDC 76045-005-11) | Available | Check wholesalers for inventory | Demand increase for the drug |
Hikma Pharmaceuticals USA, Inc. (Revised 04/11/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Morphine Sulfate, Injection, 4 mg/1 mL (NDC 0641-6125-25) | Available | Additional lots are scheduled to be manufactured. Product will be made available as it is released. | |
| Morphine Sulfate, Injection, 8 mg/1 mL (NDC 0641-6126-25) | Unavailable | Additional lots will be available in the May 2025 timeframe. Product will be made available as it is released. | Demand increase for the drug |
| Morphine Sulfate, Injection, 10 mg/1 mL (NDC 0641-6127-25) | Available | Additional lots are scheduled to be manufactured. Product will be made available as it is released. | |
| Duramorph (Morphine Sulfate Injection, USP), Injection, 1 mg/1 mL (NDC 0641-6019-10) | Available | Additional lots are scheduled to be manufactured. Product will be made available as it is released. | |
| Duramorph (Morphine Sulfate Injection, USP), Injection, .5 mg/1 mL (NDC 0641-6020-10) | Available | Additional lots are scheduled to be manufactured. Product will be made available as it is released. | |
| Infumorph 200 (Preservative-Free Morphine Sulfate Sterile Solution), Injection, 10 mg/1 mL (NDC 0641-6039-01) | Available | Additional lots are scheduled to be manufactured. Product will be made available as it is released. | |
| Infumorph 500 (Preservative-Free Morphine Sulfate Sterile Solution), Injection, 25 mg/1 mL (NDC 0641-6040-01) | Available | Additional lots are scheduled to be manufactured. Product will be made available as it is released. |
Hospira, Inc., a Pfizer Company (Revised 04/23/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Morphine Sulfate, Injection, 2 mg/1 mL Syringes (NDC 0409-1890-01) | Unavailable | Next Delivery: June 2025; Estimated Recovery: September 2025 | Other |
| Morphine Sulfate, Injection, 4 mg/1 mL Syringes (NDC 0409-1891-01) | Available | ||
| Morphine Sulfate, Injection, 8 mg/1 mL Syringes (NDC 0409-1892-01) | Unavailable | Next Delivery and Estimated Recovery: December 2028 | Other |
| Morphine Sulfate, Injection, 10 mg/1 mL Syringes (NDC 0409-1893-01) | Unavailable | Next Delivery and Estimated Recovery: December 2028 | Other |
| Morphine Sulfate, Injection, 5 mg/10 mL (0.5 mg/mL) (NDC 0409-3814-12) | Available | ||
| Morphine Sulfate, Injection, 10 mg/10 mL (1 mg/mL) (NDC 0409-3815-12) | Available | ||
| Morphine Sulfate, Injection, 50 mg/1 mL (NDC 0409-1896-20) | Unavailable | Next Delivery: July 2025; Estimated Recovery: September 2025 | Other |
| Morphine Sulfate, Injection, 50 mg/1 mL (NDC 0409-1134-05) | Unavailable | Next Delivery and Estimated Recovery: December 2028 | Other |
Piramal Critical Care Inc. (Reverified 04/15/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Mitigo (Morphine Sulfate Injection, USP), Injection, 200 mg/20 mL (NDC 66794-160-02) | Available | ||
| Mitigo (Morphine Sulfate Injection, USP), Injection, 500 mg/20 mL (NDC 66794-162-02) | Limited Availability | On allocation | Demand increase for the drug |