Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Apr 15, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Apr 15, 2022 Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... cGMP Deviations Class II Teva Pharmaceuticals USA Inc
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... Subpotent drug Class I Valor Compounding Pharmacy, Inc DBA Valor Comp...
Apr 15, 2022 Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... Failed viscosity specification - product was below specificcation Class III Akorn, Inc.
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... Subpotent drug Class I Valor Compounding Pharmacy, Inc DBA Valor Comp...
Apr 14, 2022 Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Man... Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content Class III Monarch PCM, LLC
Apr 13, 2022 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceutic... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 06... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Al... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... cGMP deviations: Temperature abuse Class III Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 met... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MF... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-352... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthc... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pha... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each... 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
Apr 13, 2022 Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz P... 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 Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-fiv... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride US... 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 Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) ... 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 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 Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, ... 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.