Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 19, 2013 | AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial,... | Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on cert... | Class II | Astellas Pharma US Inc |
| Jun 13, 2013 | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopr... | Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed. | Class II | CareFusion 213, LLC |
| Jun 6, 2013 | 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Cont... | Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the... | Class II | Hospira Inc. |
| May 31, 2013 | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, ... | Non-Sterility: The firm's contract testing laboratory found sterility failures. | Class I | Abrams Royal Pharmacy |
| May 30, 2013 | Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, si... | Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, ... | Class II | Sandoz Incorporated |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Lipotoxin 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 | Progesterone 100 mg/ml in Olive Oil 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 | Metoclopramide 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 |
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.