Browse Drug Recalls

14,396 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,396 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 14,396 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Mar 25, 2016 All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE C... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compound... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE ... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Produ... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Stanford Magic Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All T3 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PH... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Arimidex (anastrozole) Products, Rx Only, Compounded by RELIABLE DRUG/REL... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All dyclonine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx ... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All capsicum Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All boric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding 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.