Class II · Moderate risk
Vardenafil 20 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Is Vardenafil recalled?
Not under an active recall.
Vardenafil was recalled 4 times in the past — all now closed. Most recent: Jul 2, 2020.
Most common reason: Stability / shelf life (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Vardenafil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Vardenafil recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Vardenafil HCl
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Vardenafil HCl USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Vardenafil HCl Trihydrate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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