Browse Drug Recalls

70 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 70 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 70 FDA drug recalls.

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DateProductReasonClassFirm
Mar 25, 2016 All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RE... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDIN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE C... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All cetirizine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING ... 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
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 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 lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE... 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 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 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 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 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 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 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 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 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 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 Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx ... 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 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 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 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 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 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 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 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 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 methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ... Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine Class I 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 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 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 Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Produ... 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 testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... 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.