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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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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
Oct 7, 2022 AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Ca... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compo... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital C... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care C... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. Class I Viatris Inc
Oct 7, 2022 PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vita... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL sy... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTI... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Ca... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Ca... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials,... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vita... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S.... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials,... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Comp... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUT... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 6, 2022 SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL)... CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. A... Class II Southwest Iowa Renewable Energy LLC
Oct 6, 2022 Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Pat... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Golden State Medical Supply Inc.
Oct 6, 2022 Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Golden State Medical Supply Inc.
Oct 5, 2022 Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottle... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Aurobindo Pharma USA Inc.
Oct 4, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Oct 4, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Sep 30, 2022 Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured ... Out of specification for related substances (impurities). Class II Ingenus Pharmaceuticals Llc
Sep 30, 2022 Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged ... cGMP Deviations: Out of specification for assay of one of the preservative ingredients. Class II VistaPharm, Inc.
Sep 30, 2022 Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled... Subpotent Drug: Out of specification for assay Class II AuroMedics Pharma LLC
Sep 29, 2022 Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: AL... Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets Class I Golden State Medical Supply Inc.
Sep 29, 2022 Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose... Lack of Assurance of Sterility: environmental monitoring failure. Class II CIPLA
Sep 27, 2022 Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose via... Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. Class II Pfizer Inc.
Sep 26, 2022 Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx ... Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate fl... Class II AuroMedics Pharma LLC
Sep 26, 2022 Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dos... Presence of Particulate Matter: Piece of metal found in a vial Class III AuroMedics Pharma LLC
Sep 21, 2022 Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 ... Presence of Particulate Matter: A complaint was received for the presence of a single strand of h... Class II Viatris Inc
Sep 21, 2022 Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Ako... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Akorn, Inc.
Sep 21, 2022 Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Akorn, Inc.
Sep 20, 2022 oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injec... Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride ... Class III QuVa Pharma, Inc.
Sep 19, 2022 Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manu... Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 ... Class III UNICHEM PHARMACEUTICALS USA INC
Sep 16, 2022 Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT L... Failed Viscosity specification: Slightly higher OOS results obtained for viscosity Class III ALMIRALL, LLC
Sep 16, 2022 Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx... CGMP deviations: Out of specification results obtained during routine stability testing for ethan... Class II Novartis Pharmaceuticals Corporation
Sep 15, 2022 Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, ... Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. Class II RemedyRepack Inc.
Sep 15, 2022 Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 ... Lack of Assurance of Sterility Class II CIPLA
Sep 14, 2022 Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ... Failed Stability Specifications: Out of specification results reported at 12-month stability test... Class III Dr. Reddy's Laboratories, Inc.
Sep 14, 2022 Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottl... GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification... Class II Salon Technologies International Inc

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.