On July 21, 2022, Ultra Supplement LLC voluntarily recalled lot number DAP272109 of Sustango capsules packaged in ten-count blisters released for distribution to consumers. The recalled lot number had an expiry date of 4/01/2026.
The manufacturer was notified by Amazon that preliminary laboratory analysis established that the capsules contained traces of undeclared tadalafil, an ingredient in FDA-approved products for the treatment of male erectile dysfunction in the family of drugs commonly referred to as Phosphodiesterase (PDE-5) inhibitors.
Tadalafil is a PDE-5 inhibitor that is also the active ingredient in Cialis, an FDA-approved product for treating male erectile dysfunction (ED). Ultra Supplement LLC’s Sustango product is not FDA approved and is not intended to treat, cure, or prevent any disease.
Health Risks
Consumers with underlying medical issues who take Sustango capsules with undeclared tadalafil may experience a wide range of health risks. For instance, the PDE-5 inhibitors may react with nitrates found in various prescription drugs such as nitroglycerin, lowering blood pressure to life-threatening levels.
Furthermore, consumers with diabetes, heart disease or high blood pressure often take nitrates. Therefore, the concomitant use of PDE-5 inhibitors and nitrates may cause hypotension (low blood pressure), syncope (fainting), myocardial infarction (heart attack), or stroke.
Individuals with known allergies or hypersensitivities to tadalafil should not take this product. Tadalafil can cause hypotension, syncope, myocardial infarction (heart attack), stroke, increased intraocular pressure, and sudden hearing loss.
Ultra Supplement LLC has not received any reports of adverse events related to this product. However, out of an abundance of caution, the company is recalling all Sustango capsules in lot number DAP272109 and advises consumers who have purchased this product to discontinue use immediately and return it to the place of purchase for a full refund.
The recalled product is usually marketed as a dietary supplement for male enhancement and packaged in 10-count blisters packaged in a carton. The affected cartons include lot number 272109 with an expiry date of 04/01/2026.
The supplement is mostly distributed via internet and fulfilled by Amazon to all parts of the United States.
On December 17, 2020, the FDA issued a comprehensive statement warning consumers to avoid certain products found on eBay, Amazon, and other online retailers due to hidden and potentially harmful drug ingredients. It also urged all online marketplaces to ensure the safety of products listed on their platforms.
Ultra Supplement has notified all its consumers and distributors of the recall and is arranging how the recalled product will be returned to its warehouse. So, if you have purchased any Sustango capsules from lot number DAP272109, you are advised to stop using them immediately.
What Should I Do If I Have Been Affected?
If you have been affected by the recall, the first thing you need to do is stop using the product. You can then return it to the place of purchase for a full refund.
If you have any questions about the recall, contact Ultra Supplement LLC at 1-800-975-7070 Monday through Friday from 8:00 a.m. to 5:00 p.m. EST or email them at [email protected].
Consumers are also advised to contact their primary healthcare provider if they have experienced any side effects while taking the supplement.
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.
To report by regular mail, download the 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
You can also report online at www.fda.gov/medwatch/report.htm or send a fax at 1-800-FDA-0178.
This article is not intended to diagnose, treat, cure, or prevent any disease. The information contained herein is not intended to replace a one-on-one relationship with a qualified healthcare professional and is not intended as medical advice. Please be sure to consult your healthcare provider before beginning any supplement program.
The recall of Sustango Dietary Supplement was conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
