- Company Announcement Date:
- March 25, 2021
- FDA Publish Date:
- March 25, 2021
- Product Type:
- Reason for Announcement:
Recall Reason Description
Undeclared Sildenafil & Tadalafil
- Company Name:
- S&B Shopper LLC
- Brand Name:
- Product Description:
Dietary Supplement for Male Enhancement
S&B Shopper LLC is voluntarily recalling all lots of Imperial Extreme 2000mg capsules, to the consumer level. FDA analysis has found this product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in Imperial Extreme 2000mg capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumers with underlying medical issues who take Imperial Extreme 2000mg capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, S&B Shopper LLC has not received any reports of adverse events related to this recall.
The tainted product is marketed as a dietary supplement for male enhancement and is packaged in cardboard in a blister pack, 1 capsule per cardboard blister. The affected Imperial Extreme 2000mg lots include but are not limited to the following Expiration Date of 12/30/23. Imperial Extreme 2000mg was sold via the internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
S&B Shopper LLC is notifying its distributors and customers by this press release and by contacting buyers through Amazon. Consumers that have Imperial Extreme 2000mg which is being recalled should stop using and destroy them.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.