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), effective immediately.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 30, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. SpecGx LLC and any entities relying on its ANDA for manufacturing or distribution of these strengths. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Immediate (withdrawal effective upon publication).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA withdrew approval of the ANDA for methylphenidate HCl ER tablets in 27, 36, and 54 mg strengths.
Who it affects
SpecGx LLC and any entities relying on its ANDA for manufacturing or distribution of these strengths.
What you must do
Cease manufacturing and distribution of these products immediately; assess inventory and notify customers.
Deadline
Immediate (withdrawal effective upon publication).
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