Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
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.
- Total recalls
- 309
- Class I (high risk)
- 73
- Currently ongoing
- 14
- Most recent
- May 15, 2026
Most-cited firms for this cause
- Herbal Doctor Remedies70
- R Thomas Marketing, LLC24
- Flawless Beauty LLC18
- Medical Supply Liquidators Llc15
- Murray International Trading Co., Inc.14
- Novacare, LLC13
- Basic Reset Inc.11
- Dermamedics, L.L.C.9
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Taoscare Motion Sickness Patches 36-count box
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Testo-200
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Ramipril Capsules USP 10 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Ramipril Capsules USP 5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Ramipril Capsules USP 2.5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class I · High risk
Schwinnng Herbal Dietary Supplement Capsules
Marketed Without An Approved NDA/ANDA
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Artri King Reforzado con Ortiga Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class II · Moderate risk
Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class III · Low risk
Phenobarbital Elixir
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
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