SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
FDA withdraws approval of SpecGx's ANDA for methylphenidate HCl ER tablets (27, 36, 54 mg), removing these generic versions from the market.
Aforeworn detected this change in the Pharmacy & Controlled Substances space on July 30, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Pharmacies (independent, retail chains, long-term-care) that dispense or stock SpecGx's methylphenidate ER tablets in 27, 36, or 54 mg strengths. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective immediately upon publication (June 18, 2026).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmacy & Controlled Substances continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
SpecGx's abbreviated new drug application for these strengths is withdrawn; the products are no longer FDA-approved and cannot be legally marketed or dispensed.
Who it affects
Pharmacies (independent, retail chains, long-term-care) that dispense or stock SpecGx's methylphenidate ER tablets in 27, 36, or 54 mg strengths.
What you must do
Immediately stop dispensing SpecGx methylphenidate ER tablets in 27, 36, and 54 mg strengths; remove from inventory; notify prescribers and patients; transition to alternative FDA-approved products.
Deadline
Effective immediately upon publication (June 18, 2026).
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