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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

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Jul 22, 2019 Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate,... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake we... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise P... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL V... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded b... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL V... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Inj... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL... Lack of Processing Controls Class II Wise Pharmacy
Jul 19, 2019 Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bott... Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg ... Class II Lupin Pharmaceuticals Inc.
Jul 19, 2019 MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o... Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed micro... Class II Dercher Enterprises, Inc., DBA Gordon Laboratories
Jul 19, 2019 Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... Failed Dissolution Specifications Class II Ascend Laboratories LLC
Jul 18, 2019 Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manu... Failed Dissolution Specifications. Class II Ucb, Inc
Jul 18, 2019 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter... Lack of Assurance of Sterility: Bags have potential to leak. Class II Baxter Healthcare Corporation
Jul 18, 2019 Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg ... CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... Class II Preferred Pharmaceuticals, Inc
Jul 18, 2019 Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) ... Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergono... Class III Amneal Pharmaceuticals, Inc.
Jul 17, 2019 Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, pack... Subpotent Drug Class II ImprimisRx NJ
Jul 17, 2019 Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... Failed Dissolution Specifications Class II Macleods Pharma Usa Inc
Jul 17, 2019 Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottle... Subpotent Drug Class II ImprimisRx NJ
Jul 17, 2019 Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bot... Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on... Class II Lupin Pharmaceuticals Inc.
Jul 17, 2019 Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... Class III Lupin Pharmaceuticals Inc.
Jul 16, 2019 Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: ... Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enume... Class II Bionpharma Inc.
Jul 16, 2019 Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 15, 2019 LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, ... Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling o... Class II La Fresh Group, Inc.
Jul 15, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 2019 CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 2019 CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moi... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 12, 2019 Psoriasis Balm, 60 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Vertigo Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lube Lax Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alham... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lung Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-70... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Fungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(80... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Deafness Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-P, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Thyro-H, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lipidtrol Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Mental Tonic Capsules, Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Pain Away, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Re... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Thyro-Lo, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Bone Fixer, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lump Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Migraine Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies

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.