Naltrexone Hydrochloride Tablet Shortage: Supply Updates and Manufacturer Status
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The FDA has updated the shortage status for Naltrexone Hydrochloride 50 mg tablets. While some specific presentations are unavailable, several manufacturers report available supply.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on April 6, 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 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, Naltrexone.
What's in Shortage
Naltrexone Hydrochloride tablets (50 mg), a medication within the Analgesia/Addiction therapeutic category, are currently listed on the FDA drug shortage database. This shortage affects the generic form and brand-name Naltrexone Hydrochloride. The shortage was first posted on February 29, 2024, and the most recent update was provided on February 5, 2026.
Which Manufacturers Are Affected
Several manufacturers are involved in the production of Naltrexone Hydrochloride 50 mg tablets, with varying levels of availability:
- Elite Laboratories, Inc.: Multiple presentations are currently Available. Some of these are marketed by Precision Dose or Tagi Pharma. (Contact: 888-852-6657; Customer service for marketed products: 800-397-9228).
- Accord Healthcare Inc.: 50 mg tablets are Available. (Contact: 866-941-7857, option 2).
- Sun Pharmaceutical Industries, Inc.: Availability is mixed. While some presentations remain Available, others (NDC 47335-326-08 and 47335-326-18) are Unavailable and noted as currently not marketed. (Contact: 800-818-4555).
- Chartwell Molecular Holdings LLC: 50 mg tablets are Available. (Contact: 845-268-5000 Ext. 510).
- SpecGx LLC: 50 mg tablets are Available. (Contact: 800-325-8888).
Why There's a Shortage
The FDA source data does not provide a specific reason for the current shortage status of Naltrexone Hydrochloride tablets.
What Patients Should Do
If you rely on this medication, please remain proactive about your prescription. You may wish to take the following steps:
- Consult your healthcare provider: Discuss your ongoing treatment and any concerns you have regarding medication access.
- Talk to your pharmacist: Pharmacists have the most up-to-date information on local stock and can help identify which manufacturer's products are currently in their supply chain.
- Contact manufacturers: If you are having difficulty locating the medication, you may use the contact numbers listed above to inquire about supply.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should always consult with their healthcare provider or pharmacist regarding their medical treatment and medication options.
Source
Information attributed to the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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