Promethazine Hydrochloride Injection Shortage: Current Status and Manufacturer Updates

Source: FDA · United States

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

What this FDA drug-shortage notice tells you, and what most readers miss

This notice was issued by FDA on March 21, 2026 and geographically references United States. Its severity classification of "low" 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 remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Promethazine Hydrochloride) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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

Original source: FDA Official Notice ↗

All Drug Shortages →

Frequently Asked Questions

Common questions about this FDA drug-shortage notice.

What is this FDA drug-shortage notice 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 updates?
Browse the full Drug Shortages feed on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.