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:

1. Consult Your Healthcare Provider: Speak with your doctor regarding your treatment plan. Do not adjust your dosage or switch medications without professional medical guidance.
2. Talk to Your Pharmacist: Pharmacists may have information on which specific manufacturers or strengths are currently in stock at their location.
3. 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.