Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Unapproved or misbranded drugs

The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified.

309 FDA drug recalls with this cause, newest first.

Every prescription drug and most over-the-counter drugs sold in the US need either an approved application (an NDA or ANDA) or must fit an OTC monograph. A product that skips both is pulled regardless of whether anything is physically wrong with it, because its dose, purity and claims were never checked. Typical cases: compounded products sold at commercial scale, imported drugs not cleared for the US, and products whose labeling makes claims that turn them into unapproved new drugs. Supplements that turn out to contain a hidden prescription drug are filed under chemical contamination and hidden ingredients instead.

Class II · Moderate risk

Colloidal Silver

Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.

Terminated Unapproved drug Earthborn Products, Inc. D-009-2013