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Vehicle Safety

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

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Nov 2, 2016 PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/... Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... Class II Fallon Wellness Pharmacy, L.L.C.
Nov 2, 2016 Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactu... Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of... Class II Ascend Laboratories LLC
Nov 2, 2016 PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL ... Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... Class II Fallon Wellness Pharmacy, L.L.C.
Nov 1, 2016 Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/m... Lack of Assurance of Sterility: Complaints of broken tips on the ampules. Class II Hospira Inc.
Oct 28, 2016 Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 28, 2016 Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 28, 2016 Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-7... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 28, 2016 Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-7... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 24, 2016 UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: M... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 1... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 11... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration con... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 21, 2016 Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akor... Subpotent Drug: concentration of product is less than labeled amount. Class II Akorn Inc
Oct 19, 2016 Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Man... Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial ... Class II Inventia Healthcare Private Limited
Oct 12, 2016 Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx onl... Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the fir... Class II Pharmedium Services, LLC
Oct 6, 2016 Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dis... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 6, 2016 DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane ... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2016 Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx... Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the ... Class II Par Pharmaceutical, Inc.
Oct 3, 2016 Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War... Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu... Class II West-Ward Pharmaceuticals Corp.
Oct 3, 2016 PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-War... Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. Class II West-Ward Pharmaceutical
Sep 27, 2016 Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744... Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North America... Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 USCG Boat Response Kit - Product Code 80-0353, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Aid Backpack Kit - Product Code 85-0917, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-03... Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Range Trauma Kit - Product Code 85-1274, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Amphibious Trauma Kit - Product Code 85-0639, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 21, 2016 Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compo... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injecta... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounde... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded b... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wel... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wel... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC

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.