Browse Drug Recalls
2,085 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,085 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 2,085 FDA drug recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 29, 2013 | L-ArGiNINE 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Furosemide 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounde... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Clenbuterol 0.03mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Dexamethasone Sodium Phosphate 6 mg/ml Injection, compounded by Olympia Pharm... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olymp... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | HACC 270.1 Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Betamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Phar... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Vitamin 15 (HEMO15) Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Phar... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Chlorpromazine HCL 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlan... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection, compounded by Olympi... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection, compounded by Olymp... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmac... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 2... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 28, 2013 | Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main S... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Depo-Testadiiol, Main Street Compounding Pharmacy, 126 East Main Street, Newb... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Lipotropic 1.5ml PFS, Main Street Compounding Pharmacy, 126 East Main Street,... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Double Strength PGE1 40mcg/ml, Main Street Compounding Pharmacy, 126 East Mai... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Minoxidil 10% 60ml, Main Street Compounding Pharmacy, 126 East Main Street, N... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | HCG 11000u w/B-12, Main Street Compounding Pharmacy, 126 East Main Street, Ne... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Alphahydroxyprogesterone, 250mg, Main Street Compounding Pharmacy, 126 East M... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Medroxyprogesterone 150mg w/lid, 1ml Main Street Compounding Pharmacy, 126 Ea... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Medroxyprogesterone (PF) 150mg/10ml, Main Street Compounding Pharmacy, 126 Ea... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Testosterone Cypionate 250mg 10ml, Main Street Compounding Pharmacy, 126 East... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Methylprednisolone 40mg w/lidocaine 1ml, Main Street Compounding Pharmacy, 12... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Mic .05ml syrin, Main Street Compounding Pharmacy, 126 East Main Street, New... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class II | Main Street Family Pharmacy, LLC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.