CLASS I Drug recall · Reported 27 Nov 2013 · FDA Enforcement Report
Nutritional Supplement, 1 and blister packs and single pill packs recalled
Affirm XL is recalling Nutritional Supplement, 1 and blister packs and single pill packs, distributed nationwide in the US. The recall was initiated on 10 Apr 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-015-2014
- FDA event ID
- 64878
- Recalling firm
- Affirm XL, Ladera Ranch, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Apr 2013
- FDA classified
- 20 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Hidden Drug Ingredients
Timeline
| 10 Apr 2013 | Recall initiated by company | |
| 20 Nov 2013 | Classified by FDA | +224 days |
| 27 Nov 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US and Canada
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot# 1190001, exp 12/30/2013
Where was it sold?
Nationwide in the US and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.