- Company Announcement Date:
- February 15, 2021
- FDA Publish Date:
- February 16, 2021
- Product Type:
- Reason for Announcement:
Recall Reason Description
Product contains undeclared sildenafil and/or tadalafil
- Company Name:
- Brand Name:
- Product Description:
Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules
Adamssecret.co is voluntarily recalling all lots within expiry of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients in FDA approved products for the treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in Adam’s Secret Extra Strength products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.
To date, adamssecret.co has not received any reports of adverse events related to this recall.
Consumers with underlying medical issues who take Adam’s Secret Extra Strength 1500 or Adam’s Secret Extra Strength 3000 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.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets and a box containing 10 capsules. Adam’s Secret Extra Strength 1500 and 3000 were distributed via internet at www.adamssecret.co nationwide in the USA.
Adamssecret.co is notifying its customers by email and is arranging for return of all recalled products. Consumers that have Adam’s Secret Extra Strength 1500 or 3000, which is being recalled should stop using and return to place of purchase. Consumers with questions regarding this recall can contact Adamssecret.co by e-mail address [email protected] or mail at: 29-31 Industrial Ave. Fairview, NJ 07022.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or 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.