Promethazine Hydrochloride Injection Shortage: Current Status and Manufacturer Updates

Drug Shortages low FDA · · United States

The FDA reports a current shortage of Promethazine Hydrochloride Injection, with Hikma Pharmaceuticals providing updates on availability and manufacturing schedules.

What’s in Shortage

Promethazine Hydrochloride Injection (Brand Name: PROMETHAZINE HYDROCHLORIDE) is currently listed as being in shortage. This medication is an injection dosage form used across several therapeutic categories, including Analgesia/Addiction, Gastroenterology, Pediatrics, and Pulmonary/Allergy. The shortage status remains current as of the latest update.

Which Manufacturers Are Affected

Currently, the following manufacturer is listed in the database:

  • Hikma Pharmaceuticals USA, Inc.
    • Status: Available
    • Presentation: Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25)
    • Notes: Additional lots are scheduled to be manufactured. The product will be made available as it is released.
    • Contact Info: 800-631-2174

Why There’s a Shortage

No specific reason for the shortage was provided in the source data. However, the manufacturer has indicated that additional lots are being scheduled for production to meet demand.

What Patients Should Do

If you or a family member are prescribed this medication, please consider the following steps:

  • Speak with your pharmacist regarding current stock levels.
  • Consult your healthcare provider to discuss potential alternatives if the medication is unavailable at your facility.
  • Contact the manufacturer’s customer service line for information on supply availability.

Disclaimer: Patients should always consult their healthcare provider for medical advice and treatment options. Do not make changes to your medication regimen without professional medical guidance.

Source

Information provided by the FDA Drug Shortage Database.

  • Initial Posting Date: 11/21/2023
  • Last Updated: 03/12/2026

Source: FDA Official Notice

Frequently Asked Questions

What is this drug shortages alert about?
The FDA reports a current shortage of Promethazine Hydrochloride Injection, with Hikma Pharmaceuticals providing updates on availability and manufacturing schedules.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more drug shortages alerts?
Browse all drug shortages alerts on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.