Class I — UrgentReported 2024-12-11 PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Recalled by Boulla LLC
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
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Recall NumberD-0084-2025ClassificationClass IStatusOngoingCategorydrugInitiated2024-11-04Reported2024-12-11DistributionNationwide within the United StatesCode InfoLot #: 230811, Exp: 08/11/2025Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.