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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

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Jan 20, 2020 Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... Failed Dissolution Specifications: testing revealed low out of specification result in one lot o... Class III Macleods Pharma Usa Inc
Jan 15, 2020 Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use,... Lack of Assurance of Sterility Class III Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 14, 2020 methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec... Class III Hikma Pharmaceuticals USA Inc.
Jan 10, 2020 Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0... CGMP Deviations: Out of specification test result observed during retrospective review of blend u... Class III Lupin Pharmaceuticals Inc.
Jan 7, 2020 Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET W... Microbial contamination of non-sterile product. Class III Sigan Industries Inc.
Dec 26, 2019 Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ... Chemical contamination; out of specification results obtained for equipment cleaning residue rins... Class III Akorn, Inc.
Dec 20, 2019 PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, ... Superpotent Drug: Salicylic acid content is above the firm's specification. Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Dec 16, 2019 NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 13, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III The Harvard Drug Group
Dec 13, 2019 Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx... Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other i... Class III Lupin Pharmaceuticals Inc.
Dec 10, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III Lupin Pharmaceuticals Inc.
Dec 2, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For... Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. Class III AuroMedics Pharma LLC
Nov 25, 2019 VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 ... Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the pro... Class III Apothecus Pharmaceutical Corp.
Nov 20, 2019 SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, ... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deod... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net W... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 15, 2019 Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68... Defective delivery system; product is not foaming or is coming out as liquid. Class III Glenmark Pharmaceuticals Inc., USA
Nov 15, 2019 Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 15, 2019 Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100... Defective delivery system; product is not foaming or is coming out as liquid. Class III Glenmark Pharmaceuticals Inc., USA
Nov 15, 2019 Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist... Labeling mix-up - Indications on product label are incorrect. Class III Grato Holdings, Inc.
Nov 15, 2019 Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 1, 2019 Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manuf... Presence of Foreign substance: identified as a dead ant. Class III Lupin Pharmaceuticals Inc.
Nov 1, 2019 Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (ND... Presence of Foreign substance: identified as a dead ant. Class III Lupin Pharmaceuticals Inc.
Nov 1, 2019 Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufact... Presence of Foreign substance: identified as a dead ant. Class III Lupin Pharmaceuticals Inc.
Oct 22, 2019 Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manuf... Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Ato... Class III Apotex Inc.
Oct 21, 2019 PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, ... Incorrect labeling: Incorrect or missing lot and/or exp date Class III Nephron Pharmaceuticals Corporation dba Nephron...
Oct 17, 2019 Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 17, 2019 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 17, 2019 Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 16, 2019 Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10... Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. Class III Amneal Pharmaceuticals, Inc.
Oct 11, 2019 Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manuf... Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. Class III X-Gen Pharmaceuticals Inc.
Oct 4, 2019 Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar... Presence of Foreign Substance; Fiber particles. Class III KVK-Tech, Inc.
Oct 1, 2019 WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (... Subpotent Drug Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distribute... Subpotent Drug Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, D... Subpotent Drug Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) ... Subpotent Drug: Formulated amount of sennosides component is less than labelled claim. Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distri... Subpotent Drug Class III Sato Pharmaceutical Inc.
Sep 27, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose,... Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1... Class III Arbor Pharmaceuticals Inc.
Sep 24, 2019 Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by... Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle Class III Amneal Pharmaceuticals, Inc.
Sep 23, 2019 Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp,... CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles... Class III AuroMedics Pharma LLC
Sep 13, 2019 Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefille... Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... Class III GUERBET LLC
Sep 12, 2019 Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 12, 2019 ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 6, 2019 Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: ... Failed Impurities/Degradation Specifications:OOS for unknown impurity. Class III Mylan Pharmaceuticals 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.