Class I · High risk
Andropharm M1 Alpha
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
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 I · High risk
Andropharm Sten Z
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class II · Moderate risk
Caffeine Powder
Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Class III · Low risk
Indian God Lotion Spray Bottle
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
Domperidone capsules 10 mg
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Class II · Moderate risk
Zinc Acetate
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class II · Moderate risk
Oxygen Nasal Wash
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Class II · Moderate risk
Fuqingsong Relief Cream
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Te Xiao BaiNeiTing Herbal Supplement
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Ping on Ointment Relief for Muscular Pain
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Farser Kai Yeung Pill
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Wupooser Kai Yeung Pill
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Gastrodia Capsules
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
PEKING NIU-HUANG CHIEH-TU-PIEN Tablets
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
LARYNGITIS PILLS Herbal Supplement
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Tien Ma Tou Tong Wan
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Crocodile Bile Pill for Asthma
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Sciatica Pills
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Fuconpo Capsule
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
ChingChunBao ANTI-AGING TABLETS
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Patch-Remouing Pill
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
LGD-Xtreme
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Class II · Moderate risk
Renovo Patch
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Class II · Moderate risk
Menthocin Patch with Lidocaine-Strong
Marketed without an approved NDA/ANDA
Class I · High risk
Zhen Gong Fu
Marketed Without An Approved NDA/ANDA
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