FDA List of Withdrawn and or removed once approved Drugs
§ 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
Source: https://ecfr.federalregister.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.24
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act:
Adenosine phosphate:
Adrenal cortex:
Alatrofloxacin mesylate:
Aminopyrine: .
Astemizole:
Azaribine:
Benoxaprofen:
Bithionol:
Bromfenac sodium: (except ophthalmic solutions).
Bromocriptine mesylate: for prevention of physiological lactation.
Butamben:
Camphorated oil:
Carbetapentane citrate:
Casein, iodinated: .
Cerivastatin sodium:
Chloramphenicol: All oral drug chloramphenicol.
Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation.
Chlormadinone acetate:
Chloroform:
Cisapride:
Cobalt:(except radioactive forms of cobalt and its salts and cobalamin and its derivatives).
Dexfenfluramine hydrochloride:
Diamthazole dihydrochloride:
Dibromsalan:
Diethylstilbestrol: containing 25 milligrams or more of diethylstilbestrol per unit dose.
Dihydrostreptomycin sulfate:
Dipyrone:
Encainide hydrochloride:
Esmolol hydrochloride: All parenteral dosage form drug products containing esmolol hydrochloride that supply 250 milligrams/milliliter of concentrated esmolol per 10-milliliter ampule.
Etretinate: .
Fenfluramine hydrochloride:
Flosequinan:
Gatifloxacin: (except ophthalmic solutions).
Gelatin: All intravenous drug products containing gelatin.
Glycerol, iodinated: l.
Gonadotropin, chorionic: All drug products containing chorionic gonadotropins of animal origin.
Grepafloxacin:
Mepazine: All drug products containing mepazine hydrochloride or mepazine acetate.
Metabromsalan:
Methamphetamine hydrochloride:
Methapyrilene:
Methopholine:
Methoxyflurane:
Mibefradil dihydrochloride:
Nitrofurazone: (except topical drug products formulated for dermatologic application).
Nomifensine maleate:
Novobiocin sodium:
Ondansetron hydrochloride: All intravenous drug products containing greater than a 16 milligram single dose of ondansetron hydrochloride.
Oxyphenisatin:
Oxyphenisatin acetate:
Pemoline:
Pergolide mesylate:
Phenacetin:
Phenformin hydrochloride:
Phenylpropanolamine:
Pipamazine:
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl: All drug products containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, and 10 milligrams or more of bisacodyl delayed-release tablets.
Potassium arsenite:
Potassium chloride: All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion).
Povidone:
Propoxyphene:
Rapacuronium bromide:
Reserpine:
Sulfathiazole: (except for those formulated for vaginal use).
Suprofen: (except ophthalmic solutions).
Sweet spirits of nitre:
Tegaserod maleate:
Temafloxacin hydrochloride:
Terfenadine:
3,3′,4′,5-tetrachlorosalicylanilide: All drug products containing 3,3′,4′,5-tetrachlorosalicylanilide.
Tetracycline: All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter.
Ticrynafen:
Tribromsalan:
Trichloroethane: All aerosol drug products intended for inhalation containing trichloroethane.
Troglitazone: All drug products containing troglitazone.
Trovafloxacin mesylate: All drug products containing trovafloxacin mesylate.
Urethane: All drug products containing urethane.
Valdecoxib: All drug products containing valdecoxib.
Vinyl chloride:
Zirconium:
Zomepirac sodium:
[81 FR 69676, Oct. 7, 2016, as amended at 83 FR 63573, Dec. 11, 2018]