Shortage of Promethazine Hydrochloride Injection
Areazine synthesizes this FDA drug-shortage notice directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Promethazine Hydrochloride Injection is currently in shortage, with some presentations available and others temporarily on backorder from Hikma Pharmaceuticals USA, Inc.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on May 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Drug Shortages - determines the regulatory framework behind it, which shapes what mitigations (alternative therapies, allocation timelines, manufacturer guidance) are available and which agency holds oversight.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are drug-shortage, fda, medication, Promethazine Hydrochloride Injection.
What's in Shortage
The generic drug Promethazine Hydrochloride Injection, also known by brand names PROMETHAZINE HYDROCHLORIDE and PHENERGAN, is in current shortage. It is an injection dosage form and belongs to therapeutic categories including Analgesia/Addiction, Gastroenterology, Pediatric, and Pulmonary/Allergy. The shortage was first posted on 11/21/2023 and last updated on 05/12/2026.
Which Manufacturers Are Affected
The manufacturer affected is Hikma Pharmaceuticals USA, Inc. Here is the availability status for each presentation:
- Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25): Available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Contact: 800-631-2174.
- Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25): Available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Contact: 800-631-2174.
- Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35): Available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Contact: 800-631-2174.
- Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25): Unavailable. This presentation is temporarily on backorder. Contact: 800-631-2174.
- Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35): Unavailable. This presentation is temporarily on backorder. Contact: 800-631-2174.
- Phenergan, Injection, 50 mg/1 mL (NDC 0641-6085-25): Available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Contact: 800-631-2174.
- Phenergan, Injection, 25 mg/1 mL (NDC 0641-6082-25): Available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Contact: 800-631-2174.
- Phenergan, Injection, 25 mg/1 mL (NDC 0641-6084-25): Unavailable. This presentation is temporarily on backorder. Contact: 800-631-2174.
Why There's a Shortage
No specific reason for the shortage has been provided in the available data.
What Patients Should Do
Patients who depend on this medication should talk to their pharmacist or healthcare provider to check on availability and next steps. They can contact the manufacturer, Hikma Pharmaceuticals USA, Inc., using the provided contact information for updates. Patients should always consult their healthcare provider before making any changes related to their medication; this article does not provide medical advice.
Source
This information is from the FDA Drug Shortage Database, initially posted on 11/21/2023 and last updated on 05/12/2026.
Original source: FDA Official Notice ↗
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Two Areazine-derived peer sets for this FDA drug-shortage notice: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
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Similar severity timing
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