FDA pulls approval for one generic Concerta version

Patients and pharmacies that relied on methylphenidate extended-release tablets have one fewer approved generic option after the Food and Drug Administration withdrew approval of SpecGx LLC’s application. The federal notice covers 27-milligram, 36-milligram and 54-milligram tablets, and the withdrawal took effect June 18, 2026.

Effective date: June 18, 2026

SpecGx asked FDA to withdraw the approval and waived its chance for a hearing. The company’s application, ANDA 202608, had been approved in 2012.

What comes off the shelf

The product was a generic version of Concerta, the brand-name extended-release methylphenidate tablet. With the approval withdrawn, the SpecGx version is no longer an approved generic on the market.

That matters most in the ordinary places where drug options become real: a prescription being filled, an insurer’s formulary, or a pharmacy trying to substitute one version for another in the same strengths. For people who use the 27 mg, 36 mg and 54 mg tablets, the immediate change is narrower choice.

The approval ended here

The notice from FDA’s Center for Drug Evaluation and Research does not spell out why SpecGx wanted the withdrawal. It does make clear that the company initiated the request and that the approval is gone.

For readers who track medication access, the practical takeaway is simple. One approved generic path for this methylphenidate extended-release product has been removed, and any remaining supply will depend on the other versions still cleared for sale.

Agency: Food and Drug Administration, HHS Docket ID: FDA-2026-N-6382 Effective date: June 18, 2026 Contact: Kimberly Lehrfeld • Center for Drug Evaluation and Research (CDER) • 301-796-3137 • Kimberly.Lehrfeld@fda.hhs.gov • 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002