thejoe Drug recalls

Drug recalls: 17,860 FDA enforcement reports

Every drug recall the FDA has published since 2012. What was wrong, how bad the agency judged it, and where the product went.

17,860Recall reports

1,733Class I

2,624Still ongoing

1,528Firms named

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports	Share
Class II	14,424	80.8%
Class I	1,733	9.7%
Class III	1,702	9.5%
Not Yet Classified	1	0.0%

By year reported

Year	Reports
2012	434
2013	1,377
2014	1,562
2015	2,020
2016	1,254
2017	1,073
2018	1,426
2019	2,152
2020	1,035
2021	1,016
2022	1,349
2023	1,252
2024	657
2025	765
2026	488

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

By drug

Pages exist for 181 drug names with 5 or more reports on file.

Levothyroxine Sodium98 Sodium Chloride73 Methylphenidate42 Acetaminophen36 Atorvastatin Calcium35 Metformin Hydrochloride31 Valsartan29 Chlorhexidine Gluconate And Isopropyl Alcohol29 Ibuprofen26 Duloxetine Hydrochloride26 Chlorpromazine Hydrochloride24 Estradiol23 Benzalkonium Chloride21 Losartan Potassium20 Calcium Carbonate19 Aripiprazole18 Ketorolac Tromethamine18 Bupropion Hydrochloride18 Oxymetazoline Hydrochloride18 Propofol17 Lidocaine Hydrochloride17 Bupivacaine Hydrochloride17 Gabapentin17 Potassium Chloride17 Diltiazem Hydrochloride17 Cephalexin17 Carvedilol17 Cinacalcet17 Losartan Potassium And Hydrochlorothiazide16 Isotretinoin16 Valsartan And Hydrochlorothiazide16 Albuterol Sulfate15 Testosterone Cypionate15 Atomoxetine15 Dextrose Monohydrate14 Epinephrine14 Glycopyrrolate14 Methylphenidate Hydrochloride13 Pravastatin Sodium13 Fluocinolone Acetonide13 Benzocaine13 Esomeprazole Magnesium12 Morphine Sulfate12 Lorazepam12 Paroxetine Hydrochloride12 Haloperidol Decanoate12 Amlodipine And Valsartan12 Cefdinir11 Lansoprazole11 Amlodipine Besylate And Atorvastatin Calcium11 Lisdexamfetamine Dimesylate11 Doxycycline Hyclate11 Zinc Oxide11 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate11 Isopropyl Alcohol11 Carbamide Peroxide11 Fexofenadine Hydrochloride11 Heparin Sodium10 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate10 Simvastatin10 Sulfamethoxazole And Trimethoprim10 Fluconazole10 Testosterone10 Levothyroxine, Liothyronine10 Timolol Maleate10 Buspirone Hydrochloride10 Prazosin Hydrochloride10 Hydromorphone Hydrochloride9 Lisinopril9 Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose9 Famotidine9 Metoprolol Succinate9 Buprenorphine Hydrochloride9 Rifampin9 Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride9 Ezetimibe And Simvastatin9 Tolnaftate9 Tadalafil9 Oxymetazoline Hcl9 Magnesium Citrate9 Tacrolimus8 Amoxicillin8 Tizanidine8 Methylprednisolone8 Vancomycin Hydrochloride8 Glimepiride8 Divalproex Sodium8 Oxycodone Hydrochloride8 Pantoprazole Sodium8 Clotrimazole8 Rizatriptan Benzoate8 Varenicline Tartrate8 Sodium Bicarbonate8 Diazepam7 Furosemide7 Alprazolam7 Acyclovir7 Clonidine7 Fluoxetine7 Cyclosporine7 Levofloxacin7 Clobetasol Propionate7 Indomethacin7 Temozolomide7 Irbesartan7 Cefixime7 Lacosamide7 Pitavastatin Calcium7 Metoprolol Succinate Er Tablets7 Ropinirole7 Carboxymethylcellulose Sodium7 Cetirizine Hydrochloride6 Irinotecan Hydrochloride6 Diclofenac Sodium And Misoprostol6 Metoclopramide6 Budesonide6 Nicardipine Hydrochloride6 Topiramate6 Leuprolide Acetate6 Amiodarone Hydrochloride6 Amlodipine Besylate6 Enalapril Maleate6 Stannous Fluoride6 Irbesartan And Hydrochlorothiazide6 Montelukast Sodium6 Povidone-Iodine6 Amlodipine And Olmesartan Medoxomil6 Lidocaine6 Nystatin6 Mometasone Furoate6 Niacin6 Desipramine Hydrochloride6 Primidone6 Paricalcitol5 Naproxen Sodium5 Ciprofloxacin5 Clindamycin Phosphate5 Tiotropium Bromide5 Phenytoin Sodium5 Norethindrone And Ethinyl Estradiol5 Hydroxyzine Hydrochloride5 Carbamazepine5 Quinapril5 Nicotine Polacrilex5 Nitroglycerin5 Zoledronic Acid5 Methylprednisolone Acetate5 Triamcinolone Acetonide5 Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose5 Fentanyl Citrate5 Dofetilide5 Allopurinol5 Fluorescein Sodium5 Lisinopril And Hydrochlorothiazide5 Lamotrigine5 Pregabalin5 Cisatracurium Besylate5 Sirolimus5 Bupivacaine Hydrochloride And Epinephrine Bitartrate5 Phentermine Hydrochloride5 Fluocinonide5 Duloxetine5 Entecavir5 Mesalamine5 Mirtazapine5 Moxifloxacin5 Quetiapine5 Diclofenac Sodium5 Hydrocortisone Cream5 Ranitidine5 Memantine Hydrochloride5 Mepivacaine Hydrochloride5 Zonisamide5 Lidocaine Hydrochloride,Epinephrine Bitartrate5 Fexofenadine Hcl And Pseudoephedrine Hci5 Water5 Octreotide Acetate5 Doxazosin5 Rosuvastatin5 Febuxostat5 Clonazepam5

By firm

Pages exist for 147 firms with 25 or more reports on file. Below that there is not enough on the record to say anything.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.