FDA Drug recall D-015-2014
Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City,…
- FDA Drug
- Class I
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class I recall of Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City,… by Affirm Xl, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-015-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-04-10 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Affirm Xl |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot# 1190001, exp 12/30/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-015-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.