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Azacitidine Injection shortage

Current  9 presentations · 9 manufacturers · first FDA posting 2020-12-18 · last update 2026-10-15

Manufacturers: Accord Healthcare Inc., Armas Pharmaceuticals Inc, Bristol Myers Squibb Co., Dr. Reddy's Laboratories, Inc., Eugia US LLC, Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA, Inc., Meitheal Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.

Stated reasons (per FDA): Demand increase for the drug; Discontinuation of the manufacture of the drug; Other

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Presentations

PresentationManufacturerStatusReasonNotes (FDA)Dates
Azacitidine, Injection, 100 mg (NDC 16729-306-10)Accord Healthcare Inc.Current
Available
—Posted 12/21/2020
Updated 10/03/2026
Azacitidine, Injection, 100 mg (NDC 72485-201-01)Armas Pharmaceuticals IncCurrent
Limited Availability
OtherEstimated recovery: TBDPosted 12/18/2020
Updated 06/08/2026
Vidaza, Injection, 100 mg (NDC 59572-102-01)Bristol Myers Squibb Co.Current
Available
—Posted 12/18/2020
Updated 10/15/2026
Azacitidine, Injection, 100 mg (NDC 43598-305-62)Dr. Reddy's Laboratories, Inc.Current
Available
—Available to existing customersPosted 12/18/2020
Updated 09/29/2026
Azacitidine, Injection, 100 mg/4 mL (NDC 55150-393-01)Eugia US LLCCurrent
Unavailable
Demand increase for the drugOn backorder. Recovery: TBD. Check wholesalers for inventoryPosted 12/22/2020
Updated 10/02/2026
Azacitidine, Injection, 100 mg/30 mL (NDC 63323-771-39)Fresenius Kabi USA, LLCCurrent
Unavailable
Discontinuation of the manufacture of the drugDiscontinuation of the manufacture of the drugPosted 12/18/2020
Updated 10/15/2026
Azacitidine, Injection, 100 mg/ Vial (NDC 0143-9606-01)Hikma Pharmaceuticals USA, Inc.Current
Available
—Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released.Posted 12/18/2020
Updated 09/18/2026
Azacitidine, Injection, 100 mg/30 mL (NDC 71288-115-30)Meitheal Pharmaceuticals, Inc.Current
Available
—Posted 12/18/2020
Updated 08/27/2026
Azacitidine, Injection, 100 mg (NDC 68001-313-56)Teva Pharmaceuticals USA, Inc.Current
Unavailable
OtherEstimated recovery: TBDPosted 12/22/2020
Updated 10/15/2026

Source: FDA Drug Shortages Database · raw openFDA records

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