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 February 11, 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, Naltrexone) 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
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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