Ultra Supplement announces recall for undeclared tadalafil

The FDA continues to pressure manufacturers and distributors for selling products with undeclared sildenafil and tadalafil.

The agency recently announced that Wilmington Delaware–based Ultra Supplement LLC is voluntarily recalling lot number DAP272109 of Sustango capsules over the presence of tadalafil (Cialis).

The company markets the product as a supplement for men. Sustango was available for sale on Amazon.

Amazon had notified Ultra Supplement that the product appeared to be tainted with the PDE-5 inhibitor tadalafil based on laboratory analysis.

Earlier this week, FDA warned four companies over selling honey tainted with tadalafil and sildenafil.

FDA notes that consumers with a heart condition, diabetes and high blood pressure who take nitrates should avoid PDE-5 inhibitors as they may lead to dangerous blood pressure drops.

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FDA warns four companies over selling honey tainted with erectile dysfunction drugs

FDA has sent warning letters to four companies for illegally marketing honey-based products with unlisted active drug ingredients found in the erectile dysfunction drugs Cialis (tadalafil) and Viagra (sildenafil).

The agency confirmed the presence of contaminants in the products through laboratory testing.

The agency sent the warning letters to the following companies:

Thirstyrun LLC (also known as US Royal Honey LLC).  MKS Enterprise LLC. Shopaax.com.  1am USA Incorporated dba Pleasure Products USA.

FDA warned of similarly tainted products in April.

The FDA has asked the above companies to provide responses within 15 working days and a plan for how they will remedy the issue. Companies that fail to satisfy the FDA’s concerns quickly may face legal action, including product seizure or injunction.

In February, the agency released an advisory that several herbal supplements sold on Amazon were tainted with tadalafil and sildenafil, which ar…

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