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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.