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Based on the official records currently available to Public Health Trace, no recalls naming Affirm XL, Inc. are currently shown as ongoing. The 1 record below is a historical recall record.
Public Health Trace has 1 recall naming Affirm XL, Inc. as the recalling firm, republished from official FDA and USDA sources.
Recall history - 1 terminated record
Recalls by year
A bar chart of the number of recalls naming this company by year.
FDA RecallTerminatedTerminated: November 27, 2013Historical recordClass I
Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA
by Affirm XL, Inc.
Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Some FDA recall records on this page come from FDA's Enforcement Report database.
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name Affirm XL, Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
Read the full medical disclaimer.
