Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Fentanyl Citrate Injection
Status: Currently in Shortage
»Date first posted:
01/01/2012
»Therapeutic Categories: Analgesia/Addiction; Pediatric
Fresenius Kabi USA, LLC (Reverified 04/01/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20) | Available | Check wholesalers for inventory | |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-50) | Available | Check wholesalers for inventory | Demand increase for the drug |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-01) | Unavailable | Backordered. Next release April 2025. Check wholesaler for inventory. | Demand increase for the drug |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02) | Available | Check wholesalers for inventory | |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-05) | Available | Check wholesalers for inventory | |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11) | Unavailable | Backordered. Next release not available at this time. Check wholesalers for inventory. | Demand increase for the drug |
Hikma Pharmaceuticals USA, Inc. (Revised 02/14/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6247-25) | Unavailable | Additional lots will be available in the February - March 2025 timeframe. Product will be made available as it is released. | Demand increase for the drug |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6024-10) | Unavailable | Inventory available in vial presentations. | Other |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6025-10) | Unavailable | Inventory available in vial presentations. | Other |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6026-05) | Unavailable | Inventory available in vial presentations. | Other |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6027-25) | Available | Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. | |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6028-25) | Available | Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. | |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6029-25) | Available | Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. | |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6030-01) | 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 03/30/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22) | Available | ||
| Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25) | Available | ||
| Fentanyl Citrate, Injection, 500 mcg/10 mL (50 ug/1 mL) (NDC 0409-9094-28) | Available | ||
| Fentanyl Citrate, Injection, 1000 mcg/20 mL (50 ug/1 mL) (NDC 0409-9094-31) | Available | ||
| Fentanyl Citrate, Injection, 2500 mcg/50 mL (50 ug/1 mL) (NDC 0409-9094-61) | Available |