Methotrexate Sodium Injection shortage
Current 14 presentations ยท 5 manufacturers ยท first FDA posting 2023-03-13 ยท last update 2026-10-15
Manufacturers: Accord Healthcare Inc., Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA, Inc., Hospira, Inc., a Pfizer Company, Teva Pharmaceuticals USA, Inc.
Stated reasons (per FDA): Demand increase for the drug; Other
Presentations
| Presentation | Manufacturer | Status | Reason | Notes (FDA) | Dates |
|---|---|---|---|---|---|
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-30) | Accord Healthcare Inc. | Current Unavailable |
Other | Estimated recovery: October Week 1 2026; Short dated inventory with expiry of 09/30/27 available | Posted 03/13/2023 Updated 10/03/2026 |
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-35) | Accord Healthcare Inc. | Current Unavailable |
Other | Short dated inventory with expiry of 8/31/2027 available; Estimated recovery: Jan 2027 | Posted 03/13/2023 Updated 10/03/2026 |
| Methotrexate Preservative Free, Injection, 1 g (NDC 63323-122-50) | Fresenius Kabi USA, LLC | Current Available |
โ | Check wholesaler for inventory | Posted 03/13/2023 Updated 10/15/2026 |
| Methotrexate Sodium, Injection, 25 mg/1 mL (NDC 63323-123-10) | Fresenius Kabi USA, LLC | Current Available |
โ | Check wholesaler for inventory | Posted 03/13/2023 Updated 10/15/2026 |
| Methotrexate, Preservative Free, Injection, 25 mg/1 mL (NDC 0143-9519-10) | Hikma Pharmaceuticals USA, Inc. | Current Unavailable |
Demand increase for the drug | Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released. | Posted 03/13/2023 Updated 10/14/2026 |
| Methotrexate, Preservative Free, Injection, 1 g (NDC 0143-9830-01) | Hikma Pharmaceuticals USA, Inc. | Current Unavailable |
Demand increase for the drug | Additional lots will be available in the November 2026 timeframe. Short Dated Prodcut Available. | Posted 03/13/2023 Updated 10/14/2026 |
| Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-124-40) | Hospira, Inc., a Pfizer Company | Current Available |
โ | Posted 03/13/2023 Updated 10/08/2026 | |
| Methotrexate Sodium, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-10) | Hospira, Inc., a Pfizer Company | Current Available |
โ | Posted 03/13/2023 Updated 10/08/2026 | |
| Methotrexate Sodium, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-38) | Hospira, Inc., a Pfizer Company | Current Available |
โ | Posted 03/13/2023 Updated 10/08/2026 | |
| Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-25) | Hospira, Inc., a Pfizer Company | Current Available |
โ | Posted 03/13/2023 Updated 10/08/2026 | |
| Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-41) | Hospira, Inc., a Pfizer Company | Current Available |
โ | Posted 03/13/2023 Updated 10/08/2026 | |
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3671-01) | Teva Pharmaceuticals USA, Inc. | Current Limited Availability |
Other | Estimated recovery: October 2026 | Posted 03/13/2023 Updated 10/15/2026 |
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01) | Teva Pharmaceuticals USA, Inc. | Current Limited Availability |
Other | Estimated Recovery: Novemeber 2026 | Posted 03/13/2023 Updated 10/01/2026 |
| Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01) | Teva Pharmaceuticals USA, Inc. | Current Limited Availability |
Other | Estimated recovery: October 2026 | Posted 03/13/2023 Updated 10/15/2026 |
Source: FDA Drug Shortages Database ยท raw openFDA records
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