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Promethazine Hydrochloride Injection shortage

Current  10 presentations · 2 manufacturers · first FDA posting 2023-11-21 · last update 2026-10-14

Manufacturers: Hikma Pharmaceuticals USA, Inc., XGen Pharmaceuticals DJB, Inc.

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

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Presentations

PresentationManufacturerStatusReasonNotes (FDA)Dates
Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25)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 11/21/2023
Updated 09/18/2026
Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25)Hikma Pharmaceuticals USA, Inc.Current
Limited Availability
Demand increase for the drugEstimated recovery: TBDPosted 11/21/2023
Updated 09/18/2026
Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35)Hikma Pharmaceuticals USA, Inc.Current
Available
Demand increase for the drugLimited availabilityPosted 11/21/2023
Updated 09/18/2026
Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35)Hikma Pharmaceuticals USA, Inc.Current
Available
—Additional lots are scheduled to be manufactured. Product will be made available as it is released.Posted 11/21/2023
Updated 10/14/2026
Phenergan, Injection, 25 mg/1 mL (NDC 0641-6082-25)Hikma Pharmaceuticals USA, Inc.Current
Unavailable
OtherAdditional lots are scheduled to be manufactured. Product will be made available as it is released.Posted 11/21/2023
Updated 09/18/2026
Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25)Hikma Pharmaceuticals USA, Inc.Current
Unavailable
—Additional lots are scheduled to be manufactured. Product will be made available as it is released.Posted 11/21/2023
Updated 09/18/2026
Phenergan, Injection, 25 mg/1 mL (NDC 0641-6084-25)Hikma Pharmaceuticals USA, Inc.Current
Unavailable
OtherEstimated recovery: TBDPosted 11/21/2023
Updated 10/14/2026
Phenergan, Injection, 50 mg/1 mL (NDC 0641-6085-25)Hikma Pharmaceuticals USA, Inc.Current
Unavailable
OtherEstimated recovery: TBDPosted 11/21/2023
Updated 10/14/2026
Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 39822-5525-3)XGen Pharmaceuticals DJB, Inc.Current
Available
—Posted 11/21/2023
Updated 09/22/2026
Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 39822-5550-6)XGen Pharmaceuticals DJB, Inc.Current
Unvailable
Demand increase for the drugEstimated recovery: TBDPosted 11/21/2023
Updated 09/22/2026

Source: FDA Drug Shortages Database · raw openFDA records

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