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 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 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 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 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 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 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 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 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 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 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 lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compound... 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 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 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 betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRU... 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 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 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 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 potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE... 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.