FDA Alert: Dietary Supplement Sold on Amazon Recalled for Presence of Prescription Drug Ingredients

Recalled dietary supplement sold on Amazon

The product was distributed via the internet and fulfilled by Amazon 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.


Dietary Supplement Sold on Amazon Recalled for Containing Prescription Drug Ingredients

Esupplementsales, LLC was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Hard Dawn Rise and Shine Capsules renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.


Maryland Woman Inadvertently Buys Counterfeit Supplements on Amazon.com

Annapolis, Maryland resident Michele Marshall maintains she received counterfeit supplements from Amazon.com. Ms. Marshall purchased a probiotic supplement called Align from Amazon.com in April 2019. The actual seller was a third-party site offering the supplements for sale as a ‘Prime’ purchase, meaning the product is guaranteed to arrive in 2 days and is promoted among the first offering seen by Amazon customers when they conduct a product search.