Browse Drug Recalls

105 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 105 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 105 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Gentamicin 0.3% 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 Caco/Copper 6. 2 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 Deslorelin 15 mg vial, 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 Aminocaproic Acid 0.5mg/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 Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection, com... 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 Papaverine 40 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 Pentosan 250 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 Detomidine w/Xylazine 100 mg/mg Injection, compounded by Olympia Pharmacy, Or... 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 Quadmix, 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 Tripelennamine 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 Tacrolimus (0.02% and 0.03%) drops, 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 Medetomidine 2 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

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.