Company Pulls Three Doses of Extended-Release Ritalin
Published Date: 6/18/2026
Notice
Summary
SpecGx LLC has asked the FDA to withdraw its approval for three strengths (27 mg, 36 mg, and 54 mg) of its methylphenidate extended-release tablets, effective June 18, 2026. This means these specific versions of the medicine will no longer be allowed on the market. Patients and pharmacies using these doses should look for alternatives, but no extra costs or penalties are mentioned.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
Three methylphenidate ER strengths withdrawn
If you use SpecGx's methylphenidate hydrochloride extended-release (ER) tablets in 27 mg, 36 mg, or 54 mg strengths, those specific products are no longer allowed on the market starting June 18, 2026. Patients and pharmacies using these exact strengths should seek alternative products or doses.
Interstate distribution becomes illegal for withdrawn products
As of June 18, 2026, distributing SpecGx's methylphenidate HCl ER tablets in 27 mg, 36 mg, or 54 mg into interstate commerce without an approved application is illegal and may lead to regulatory action under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. Pharmacies, distributors, or sellers handling these specific products must stop interstate distribution to avoid enforcement.
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