# FDA recall D-015-2014

> **Affirm XL, Inc.** · Class I · drug recall initiated 2013-04-10.

## 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 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.

## Distribution

Nationwide in the US and Canada

## Key facts

- **Recall number:** D-015-2014
- **Recalling firm:** Affirm XL, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-04-10
- **Report date:** 2013-11-27
- **Termination date:** 2013-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ladera Ranch, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-015-2014

## Citation

> AI Analytics. FDA recall D-015-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-015-2014. Source: US FDA. Licensed CC0.

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