Browse Drug Recalls

1,528 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,528 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 1,528 FDA drug recalls in FL.

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DateProductReasonClassFirm
May 29, 2013 Cre-O-Pan 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 Altrenogest 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 Xylazine 300 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 Gaba 50 mg/Mag Sulfate 50 mg/Taurine/Theanine 50 mg/ml Injection, compounded ... 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 ITPP 50 mg/ml DMG 100 mg/ml Injection, compounded by Olympia Pharmacy, Orland... 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 Testosterone Cypionate (100 mg/ml & 200 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 Vitamin B12 (3000 mcg/ml & 5000 mcg/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 Gentamicin Sulfate 80 mg/ml Injection, compounded by Olympia Pharmacy, Orland... 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 Enrofloxacin 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 Idoxuridine 0.1% 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 Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orland... 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 Trimix, 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 Praziquantel 56.8mg/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 Sermorelin/GHRP 3 mg/3 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 Guanabenz 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 Stanozolol (50 mg/ml and 100 mg/ml) 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 Pento-Gluc 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 HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, 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 Gentamicin 300 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 Phenobarbital 62. 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 Dextrose 50% Solution, 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 Iodide 20% 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 Fluphenazine 25 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 Bi mix, 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 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia... 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 Guanabenz 8 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 Adenosine-Mono-Phosphate Injection, 200 mg/ml, 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 Cal-Phos 1000 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 Phentolamine 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 Diphenhydramine 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 Detomidine 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 Estradiol Cypionate 10 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 Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orla... 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 Oxytocin 20 units/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 Acepromazine 25 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 Glutathione 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 Atropine Sulfate 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 Dexpanthenol 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 Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, 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 Metabolase 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 Ketamine 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 Diclazuril 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 20, 2013 XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutram... Class I Dolphin Intertrade Corporation
May 20, 2013 JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutram... Class I Dolphin Intertrade Corporation
May 15, 2013 Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactu... Failed Impurity/Degradation Specification; "Related Compound C" Class II Actavis South Atlantic LLC
May 15, 2013 HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufa... Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and C... Class II Health & Beyond
May 10, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec... Class I Apotex Corp.
May 7, 2013 Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 11... Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
May 2, 2013 Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Pap... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded b... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.

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.