U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Enforcement Activities | FDA
  5. Unapproved Prescription Drugs | Drugs Marketed in the United States That Do Not Have Required FDA Approval
  6. Compliance Actions by Drug Class
  1. Enforcement Activities | FDA

Compliance Actions by Drug Class

Since the Compliance Policy Guide was published, FDA has removed numerous unapproved drug products from the market. Generally, the Agency has focused its enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs.

Balanced Salt Solution (ophthalmic) Drug Products

Carbinoxamine Drug Products

Codeine Sulfate, Codeine Phosphate or Dihydrocodeine Bitartrate Oral and Injectable Drug Products

Codeine Sulfate Tablets

Colchicine Products

Single-ingredient Oral Colchicine Products

Injectable Colchicine Products

Cough, Cold, and Allergy Products 

Epinephrine 0.3 mg prefilled single dose syringe

Ergotamine-Containing Drug Products

Timed-Release Drug Products Containing Guaifenesin

Hydrocodone Drug Products

Isometheptene-Containing Drug Products

Unapproved Narcotics Containing Morphine Sulfate, Hydromorphone, or Oxycodone

Unapproved Nitroglycerin Sublingual Tablets

Unapproved Ophthalmic Drug Products

     Fluorescein Injection

     Freshkote Sterile Ophthalmic Solution

    Pilocarpine Hydrochloride Ophthalmic Solutions

Unapproved Otic Drug Products

  • Unapproved and Misbranded Otic Prescription Drug Products

Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration


Topical Drug Products Containing Papain

Quinine Sulfate Drug Products

Sodium Nitrite Injection and Sodium Thiosulfate Injection Products

Trimethobenzamide Hydrochloride Suppositories

  • FDA News: FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide (Issued April 6, 2007)
  • Federal Register Notice [HTML] [PDF] (April 9, 2007)

Back to Top