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

Carbo-O-Philic 40 Gel 40%

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Terminated Unapproved drug Geritrex Corp NDC 54162-016-15 D-0391-2016
Class II · Moderate risk

Carbo-O-Philic 40 Cream 40%

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Terminated Unapproved drug Geritrex Corp NDC 54162-640-03 D-0390-2016
Class I · High risk

Xcellerator

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Terminated Unapproved drug Novacare, LLC D-0973-2016
Class I · High risk

TruTrim (product not labeled)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Terminated Unapproved drug Novacare, LLC D-0967-2016
Class III · Low risk

Monistat 1 Simple Cure

Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.

Terminated Unapproved drug Medtech Products, Inc. NDC 63736-013-30 D-1077-2015
Class II · Moderate risk

Compounded Plaquex

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Terminated Unapproved drug AnazaoHealth Corporation D0384-2015
Class II · Moderate risk

B-Lipo

Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss

Terminated Unapproved drug Bethel Nutritional Consulting, Inc D-0424-2015
Class I · High risk

Professional Formexx Black

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Terminated Unapproved drug Anabolic Science Labs, LLC D-0990-2015
Class I · High risk

Swoll-250 Super Mass Builder Quad Stack

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Terminated Unapproved drug Anabolic Science Labs, LLC D-0989-2015
Class I · High risk

Estrastain Pro-Anabolic Mass and Hardening Complex

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Terminated Unapproved drug Anabolic Science Labs, LLC D-0988-2015
Class I · High risk

7-Ment Alpha Advanced Mass Builder

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Terminated Unapproved drug Anabolic Science Labs, LLC D-0987-2015
Class I · High risk

Halo-70 Mega Mass Builder

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Terminated Unapproved drug Anabolic Science Labs, LLC D-0986-2015
Class I · High risk

M14-Ment Advanced Mass Builder

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Terminated Unapproved drug Anabolic Science Labs, LLC D-0985-2015
Class I · High risk

M1-Alpha Labs Mega Mass Builder

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Terminated Unapproved drug Anabolic Science Labs, LLC D-0984-2015