What happened
Original notice title
Umbrella MARCS-CMS 612037, May 18, 2021
From the archived source record
As described below, these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 301(d)] and misbranded drugs sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)]. “Alpha Male Plus” FDA confirmed through laboratory analysis that a sample of your “Alpha Male Plus” contains the undeclared active pharmaceutical ingredient tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. FDA has issued a warning to consumers not to use “Alpha Male Plus” (see Alpha Male Plus Immediate Public Notification [see original source] Dietary supplementation with NACET improves the bioavailability of NAC in tissue cells (i.e. lung tissue at risk of COVID-19 induced oxidative damage). . . . The safe bet now is to prepare to deal with infeciton [sic] rather than naively hoping to avoid it. Did you know . . . that dietary supplementation with NACET improves the bioavailability of NAC in tissue cells (i.e. lung tissue at risk of COVID-19 induced oxidative damage). . . . FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 1 Furthermore, FDA has warned consumers ([see original source] about products containing tianeptine, which is used as a prescription drug in some European, Asian, and Latin American countries, but is not approved as a drug in the United States.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- c496fc460c5a
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →