Shortage of Methylphenidate Hydrochloride Extended-Release Tablets

Source: FDA · United States

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.

The FDA reports a current shortage of Methylphenidate Hydrochloride extended-release tablets, with some strengths available, others limited, and a few unavailable from certain manufacturers.

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

This notice was issued by FDA on April 7, 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, Methylphenidate Hydrochloride.

Shortage of Methylphenidate Hydrochloride Extended-Release Tablets

What's in Shortage

The generic drug name is Methylphenidate Hydrochloride Tablet, Extended Release. Brand names include RELEXXII, METHYLPHENIDATE HYDROCHLORIDE, and CONCERTA. The dosage form is Tablet, and the current status is ongoing. It belongs to the Psychiatry therapeutic category. The shortage was first posted on 07/26/2023 and last updated on 04/02/2026.

Which Manufacturers Are Affected

  • Vertical Pharmaceuticals, LLC: Available for presentations such as 72 mg (NDC 68025-084-30), 63 mg (NDC 68025-089-30), 36 mg (NDC 68025-097-30), 18 mg (NDC 68025-095-30), 45 mg (NDC 68025-088-30), and 54 mg (NDC 68025-098-30); Unavailable for 18 mg (NDC 68025-095-10), 36 mg (NDC 68025-097-10), 54 mg (NDC 68025-098-10), and 27 mg (NDC 68025-096-10), with estimated recovery TBD. Contact: 800-541-4802.
  • Trigen Laboratories, LLC: Limited Availability for presentations such as 18 mg (NDC 13811-706-10), 54 mg (NDC 13811-709-10), 27 mg (NDC 13811-707-10), 63 mg (NDC 13811-700-30), 45 mg (NDC 13811-711-30), 36 mg (NDC 13811-708-10), and 72 mg (NDC 13811-710-30), with allocation to current contracted customers. Contact: 800-541-4802.
  • Teva Pharmaceuticals USA, Inc.: Available for 27 mg (NDC 62037-734-01), 54 mg (NDC 62037-727-01), 18 mg (NDC 62037-725-01), and 36 mg (NDC 62037-726-01). Contact: 800-545-8800.
  • Janssen Pharmaceuticals: Available for 27 mg (NDC 50458-588-01), 18 mg (NDC 50458-585-01), 54 mg (NDC 50458-587-01), and 36 mg (NDC 50458-586-01). Contact: 800-JANSSEN (1-800-526-7736) Monday through Friday from 9:00 AM to 8:00 PM ET.
  • Lannett Company, Inc.: Available for 18 mg (NDC 62175-310-37) and 27 mg (NDC 62175-311-37); Limited Availability for 36 mg (NDC 62175-312-37); Unavailable for 54 mg (NDC 62175-313-37). Contact: 844-834-0530.

Why There's a Shortage

No specific reason was provided in the FDA Drug Shortage Database for this shortage.

What Patients Should Do

Patients who depend on this medication are encouraged to speak with their pharmacist or healthcare provider to check on availability and explore options. They may also contact the relevant manufacturer for further details. Please remember, patients should always consult their healthcare provider before making any changes related to their medication.

Source

This information is sourced from the FDA Drug Shortage Database, last updated on 04/02/2026.

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

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.

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 Methylphenidate Hydrochloride extended-release tablets, with some strengths available, others limited, and a few unavailable from certain manufacturers.
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 "medium" severity. Stay informed and follow agency guidance.
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.