Is Levitra Discontinued? What Happened to Levitra and Staxyn, and What Replaced Them

What the FDA record says

In letters dated September 26, 2019, September 24, 2020 and September 20, 2021, Bayer HealthCare Pharmaceuticals notified FDA that Levitra 5 mg, 10 mg and 20 mg tablets were being discontinued (the 2.5 mg tablet had been discontinued earlier, in 2018). On May 3, 2023 FDA published its determination that the tablets were not withdrawn from sale for reasons of safety or effectiveness. That finding matters because it is the legal basis on which generic manufacturers may keep referencing Levitra in their applications.

Staxyn, the 10 mg orally disintegrating brand, was later withdrawn as well. A generic vardenafil ODT exists; MedlinePlus lists it alongside the tablet and warns the two formats are not interchangeable.

Sources: Federal Register (FDA): FDA determination on Levitra withdrawal (2023) · MedlinePlus: Vardenafil patient information

What you can get instead

Sources: FDA: Compounding: questions and answers · RedBox Rx: RedBox Rx vardenafil page · Sesame Care: Sesame vardenafil page · Marley Drug: Marley Drug vardenafil page

If a site still sells “Levitra”

A U.S.-facing site offering brand Levitra today, especially without a prescription, is not dispensing Bayer's product. FDA's guidance on buying medicines online lists the checks: prescription required, state-licensed pharmacy, a licensed pharmacist you can reach, and a price that is not implausibly low.

Sources: FDA: Buying medicines safely online

Switching from Levitra to generic vardenafil

The generic tablet has the same strengths as the brand had. The prescribing information keeps the same cautions: no nitrates or riociguat, an individualized plan with alpha-blockers, and care in people with QT-prolongation risk. If your Levitra prescription is old, a new visit is needed anyway; use it to confirm the strength, the format and any medicines you have started since.

Sources: DailyMed: Vardenafil prescribing information