# 2026-12236: Company Pulls Three Doses of Extended-Release Ritalin

2026-12236, SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-06-18, effective 2026-06-18; PRIA reads it as touching household money (as of 2026-06-25).

- Canonical: https://policyrisk.com/federal-register/2026-12236
- As of: 2026-06-25
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12236
- Title: SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 36865
- Published: 2026-06-18
- Effective: 2026-06-18
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-25

## In one line

Company Pulls Three Doses of Extended-Release Ritalin

## 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.

## Abstract

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 mg, and 54 mg, held by SpecGx LLC (SpecGx), 385 Marshall Ave., Webster Groves, MO 63119. SpecGx requested withdrawal of approval of this application and has waived its opportunity for a hearing.

## Effects PRIA read

- Three methylphenidate ER strengths withdrawn: cost, low. 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- Interstate distribution becomes illegal for withdrawn products: cost, low. 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, distrib…

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## Sources
- [2026-12236 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/18/2026-12236/specgx-llc-withdrawal-of-approval-of-abbreviated-new-drug-application-for-methylphenidate)
- [2026-12236 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-18/pdf/2026-12236.pdf)

## Related
- [Previous: 2026-12235, Advisory Committee; Science Board to the Food and Drug Administration; Renewal](https://policyrisk.com/federal-register/2026-12235)
- [Next: 2026-12237, Agency Information Collection Activities; Submission for Office of Management a…](https://policyrisk.com/federal-register/2026-12237)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12236 (as of 2026-06-25).