FDA Drug Shortage Database
Fentanyl (Sublimaze) shortage
The FDA Drug Shortage Database lists 7 of 19 fentanyl presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on January 1, 2012. 12 more presentations are on the list as available.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the FDA Drug Shortage Database.
Which strengths are short?
| Strength | Limited or unavailable now | Listed now, available | Resolved or discontinued |
|---|---|---|---|
| 1ml injection | 3 | 1 | 0 |
| 05mg/1ml injection | 1 | 4 | 0 |
| 50mcg/1ml injection | 0 | 5 | 0 |
| 100mcg/2ml injection | 0 | 1 | 0 |
| 250mcg/5ml injection | 1 | 0 | 0 |
| 500mcg/10ml injection | 1 | 0 | 0 |
| 1000mcg/20ml injection | 1 | 0 | 0 |
| 2500mcg/50ml injection | 0 | 1 | 0 |
Which presentations are listed?
Limited or unavailable now (7)
| Presentation | Company | Status and dates | Availability and reason given |
|---|---|---|---|
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02) | Fresenius Kabi USA, LLC | Current posted January 1, 2012, updated September 15, 2026 | Unavailable; Other |
| Fentanyl Citrate, Injection, 1000 mcg/20 mL (50 ug/1 mL) (NDC 0409-9094-31) | Hospira, Inc., a Pfizer Company | Current posted January 1, 2012, updated September 22, 2026 | Limited Availability; Demand increase for the drug |
| Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25) | Hospira, Inc., a Pfizer Company | Current posted January 1, 2012, updated September 22, 2026 | Limited Availability; Demand increase for the drug |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6024-10) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Unavailable; Other |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6025-10) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Unavailable; Other |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6026-05) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Unavailable; Other |
| Fentanyl Citrate, Injection, 500 mcg/10 mL (50 ug/1 mL) (NDC 0409-9094-28) | Hospira, Inc., a Pfizer Company | Current posted January 1, 2012, updated September 22, 2026 | Limited Availability; Demand increase for the drug |
Listed now, available (12)
| Presentation | Company | Status and dates | Availability and reason given |
|---|---|---|---|
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-01) | Fresenius Kabi USA, LLC | Current posted January 1, 2012, updated October 6, 2026 | Available |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-05) | Fresenius Kabi USA, LLC | Current posted January 1, 2012, updated October 6, 2026 | Available |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20) | Fresenius Kabi USA, LLC | Current posted January 1, 2012, updated October 6, 2026 | Available |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-50) | Fresenius Kabi USA, LLC | Current posted January 1, 2012, updated October 6, 2026 | Available |
| Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22) | Hospira, Inc., a Pfizer Company | Current posted January 1, 2012, updated September 22, 2026 | Available |
| Fentanyl Citrate, Injection, 2500 mcg/50 mL (50 ug/1 mL) (NDC 0409-9094-61) | Hospira, Inc., a Pfizer Company | Current posted January 1, 2012, updated September 22, 2026 | Available |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6027-25) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Available |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6028-25) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Available |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6029-25) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Available |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6030-01) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Available |
| Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6247-25) | Hikma Pharmaceuticals USA, Inc. | Current posted December 20, 2023, updated September 18, 2026 | Available |
| Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11) | Fresenius Kabi USA, LLC | Current posted January 1, 2012, updated October 6, 2026 | Available |
Source: FDA Drug Shortage Database via openFDA, read October 8, 2026
Are medicines for the same conditions short too?
Medicines whose labels share an indication with this one, and their own shortage status; listed as records, not substitutes.
| Medicine | Shared indication | Shortage | Generic labelers | Pharmacy cost |
|---|---|---|---|---|
| Lidocaine | Pain | In shortage | 81 labelers | $0.154 per gram 5% ointment |
Source: FDA drug labels, FDA Drug Shortage Database, NDC Directory, CMS NADAC of October 7, 2026 (FDA files October 8, 2026)
What next?
- Every shortage now
- medicines by presentations in shortage