Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
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Recall NumberD-0397-2026ClassificationClass IStatusOngoingCategorydrugInitiated2025-12-15Reported2026-03-11DistributionProduct was distributed to 4 customers in the US.Code InfoAll codes; Exp 12/31/2029Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.