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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

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Presentations

PresentationManufacturerStatusReasonNotes (FDA)Dates
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-30)Accord Healthcare Inc.Current
Unavailable
OtherEstimated recovery: October Week 1 2026; Short dated inventory with expiry of 09/30/27 availablePosted 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
OtherShort dated inventory with expiry of 8/31/2027 available; Estimated recovery: Jan 2027Posted 03/13/2023
Updated 10/03/2026
Methotrexate Preservative Free, Injection, 1 g (NDC 63323-122-50)Fresenius Kabi USA, LLCCurrent
Available
โ€”Check wholesaler for inventoryPosted 03/13/2023
Updated 10/15/2026
Methotrexate Sodium, Injection, 25 mg/1 mL (NDC 63323-123-10)Fresenius Kabi USA, LLCCurrent
Available
โ€”Check wholesaler for inventoryPosted 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 drugAdditional 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 drugAdditional 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 CompanyCurrent
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 CompanyCurrent
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 CompanyCurrent
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 CompanyCurrent
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 CompanyCurrent
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
OtherEstimated recovery: October 2026Posted 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
OtherEstimated Recovery: Novemeber 2026Posted 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
OtherEstimated recovery: October 2026Posted 03/13/2023
Updated 10/15/2026

Source: FDA Drug Shortages Database ยท raw openFDA records

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