Browse Drug Recalls

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Apr 13, 2022 Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Man... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distribut... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 0409... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major P... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 met... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmac... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex co... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx on... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), pac... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Ph... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured b... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate i... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic so... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Ph... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dos... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: San... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset T... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), package... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 m... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Ma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx o... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bot... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medica... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: M... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Phar... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3m... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL singl... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple d... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office

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.