- Two sexual supplements were voluntarily recalled after Amazon flagged an unapproved ingredient.
- Tadalafil is approved for use in some prescription ED drugs, but not for unregulated dietary supplements.
- Consumers who take the supplements may not realize they're at risk for adverse drug interactions.
Two sexual supplements marketed to men — "The Red Pill That Never Sleeps" and "Hard Dawn Rise and Shine" — have been found to contain an unapproved erectile dysfunction drug, prompting voluntary recalls of select batches.
According to a recall announcement posted Tuesday, Amazon informed the vendor Your Favorite Shop that some of its little Red Pills were found to be "tainted by tadalafil" in a laboratory analysis, prompting the company to recall one lot of the product.
The US Food and Drug Administration has approved the use of tadalafil, a blood vessel dilator, in ED medications such as Cialis and Adcirca. However, dietary supplements like The Red Pill and Hard Dawn are not subject to the same FDA review process and therefore aren't approved to contain the active ingredient.
Esupplementsales, the vendor that sells Hard Dawn Rise and Shine, issued a similar voluntary recall of one batch of the pills January 28, citing safety and efficacy concerns.
Taking unapproved supplements comes with health risks
Unchecked claims promising a boost in sexual vigor or fitness are nothing new for the online supplement marketplace. That could mean the pills you order on Amazon are probably fake, or worse; they could contain an active ingredient that's not listed on the label.
Consumers who purchased The Red Pill or Hard Dawn may not consider how the pill interacts with other medications, especially if they think they're taking an herbal supplement (as it's advertised on the Hard Dawn package).
But taking tadalafil along with certain prescription drugs can lower blood pressure to dangerous levels, according to the recall notices. People with medical conditions such as diabetes, high blood pressure, or heart disease who take drugs containing nitrates are at risk for a potentially life-threatening reaction if they take tadalafil.
Both supplement vendors are alerting consumers via press release and Amazon message if they purchased an affected batch. The recalled product lots were numbered 26436989 (The Red Pill) and 2107 (Hard Dawn).
Neither company responded immediately to Insider's requests for comment.