What happened
Original notice title
Wave Miami LLC MARCS-CMS 590422, January 13, 2020
From the archived source record
Food and Drug Administration (FDA) has reviewed the information on your website, [see original source] and Facebook pages, [see original source] and [see original source] and determined that you market and offer a product for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, FDA has determined that the “Lipro Dietary Capsule” product you offer for sale is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)]. Furthermore, this product is a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)]. FDA confirmed through laboratory analysis that your “Lipro Dietary Capsule” contains undeclared tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. Tadalafil is the active pharmaceutical ingredient in Cialis, used to treat erectile dysfunction (ED). 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 “Lipro Dietary Capsule” (see Lipro Dietary Capsule Immediate Public Notification). Although you engaged in communication with the Agency regarding a recall of “Lipro Dietary Capsule” on (b)(4) , to date your firm has not voluntarily recalled the product. We continue to recommend that the product be recalled from the market. Unapproved New Drug “Lipro Dietary Capsule” is a drug as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] because it is intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Misbranded Drug Your “Lipro Dietary Capsule” product is also misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] in that the labeling for this drug fails to bear adequate directions for use.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 34fbfdaa5eb7
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.
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