Methylphenidate Hydrochloride Extended-Release Tablet Shortage: Supply Updates and Manufacturer Status
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A shortage of Methylphenidate Hydrochloride extended-release tablets, used in psychiatry, is ongoing due to active ingredient supply issues affecting several manufacturers.
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 "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 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, Methylphenidate) 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
Generic Name: Methylphenidate Hydrochloride Tablet, Extended Release
Brand Names: Concerta, Relexxii, Methylin ER
Dosage Form: Tablet, Extended Release (various strengths including 10 mg, 18 mg, 20 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg)
Therapeutic Category: Psychiatry
Current Status: Ongoing shortage
Initial Posting Date: 07/26/2023
Last Updated: 02/02/2026
Which Manufacturers Are Affected
Availability varies significantly by manufacturer and dosage strength:
- Janssen Pharmaceuticals (Concerta): All strengths (18 mg, 27 mg, 36 mg, 54 mg) are currently Available.
Contact: 800-526-7736 - Teva Pharmaceuticals USA, Inc.: Most strengths (27 mg, 36 mg, 54 mg) are Available; 18 mg is under Limited Availability.
Contact: 800-545-8800 - Vertical Pharmaceuticals, LLC (Relexxii): Mixed status. Several strengths (18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg) are Available, while specific NDCs for 18 mg, 27 mg, 36 mg, and 54 mg are Unavailable with recovery dates to be determined.
Contact: 800-541-4802 - SpecGx LLC: Most strengths (20 mg, 27 mg, 36 mg, 54 mg) have Limited Availability. The 10 mg strength (Methylin ER) is Unavailable, with the next release expected in late Q2.
Contact: 800-325-8888 - Trigen Laboratories, LLC: All strengths (18 mg through 72 mg) have Limited Availability and are under allocation to current contracted customers.
Contact: 800-541-4802 - Lannett Company, Inc.: 18 mg is Available; 27 mg, 36 mg, and 54 mg are Unavailable.
Contact: 844-834-0530 - Sun Pharmaceutical Industries, Inc.: All presentations (18 mg, 27 mg, 36 mg, 54 mg) are Unavailable as they are currently not marketed.
Contact: 800-818-4555
Why There's a Shortage
The FDA reports that the primary reason for this shortage is a shortage of an active ingredient required to manufacture the medication.
What Patients Should Do
If you are affected by this shortage, please consider the following steps:
- Consult Your Healthcare Provider: Speak with your doctor regarding your treatment plan. Do not adjust your dosage or switch medications without professional medical guidance.
- Talk to Your Pharmacist: Pharmacists may have information on which specific manufacturers or strengths are currently in stock at their location.
- Contact Manufacturers: You may use the contact information provided above to inquire about supply timelines for specific products.
Disclaimer: This information is for educational purposes only. Patients should always consult with their healthcare provider or pharmacist regarding medical concerns and treatment options.
Source
Information provided by the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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