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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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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

18,041 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,041 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 18,041 FDA drug recalls.

DateProductReasonClassFirm
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 9, 2019 Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals,... Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... Class II Asclemed USA Inc. dba Enovachem Pharmaceuticals
Dec 9, 2019 Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals,... Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... Class II Asclemed USA Inc. dba Enovachem Pharmaceuticals
Dec 9, 2019 Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals,... Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... Class II Asclemed USA Inc. dba Enovachem Pharmaceuticals
Dec 6, 2019 Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, D... Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total ... Class I Lannett Company, Inc.
Dec 4, 2019 Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... Failed Dissolution Specifications: Low out of specification results obtained during stability tes... Class II American Health Packaging
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
Dec 2, 2019 Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufact... Presence of Foreign Substance: Presence of a foreign object in a single tablet. Class II Jubilant Cadista Pharmaceuticals, Inc.
Dec 2, 2019 Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03),... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Preferred Pharmaceuticals, Inc
Nov 27, 2019 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,... Labeling: Incorrect or Missing Lot and/or expiration date. Class II Pfizer Inc.
Nov 26, 2019 Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road... Presence of Foreign Substance: Foreign material found inside the vial (manufacturer). Class II SCA Pharmaceuticals, LLC
Nov 25, 2019 Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-co... Discoloration: Product complaints of discoloration after reconstitution of vials. Class II 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 25, 2019 Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 11... Cross contamination with other products: undeclared contaminants of phenol and camphor in petrole... Class II OraLabs, Incorporated
Nov 25, 2019 Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Pa... Failed Impurities/Degradation Specifications Class II Medisca, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 21, 2019 EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 m... Sub Potent Drug: Out of Specification (OOS) Class II Pacira Pharmaceuticals, Inc.
Nov 21, 2019 Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferre... Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Preferred Pharmaceuticals, Inc
Nov 20, 2019 Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
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 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 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 Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), ... CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... Class II American Health Packaging
Nov 20, 2019 Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
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 19, 2019 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare... Lack of Assurance of Sterility: Product has the potential to leak. Class II Baxter Healthcare Corporation
Nov 19, 2019 Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma US... Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 coun... Class II AuroMedics Pharma LLC
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 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 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 MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3... Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP ... Class II Akorn, 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 14, 2019 AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. ... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, I... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Nov 14, 2019 Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in... cGMP violations Class II Wisconsin Pharmacal Company, LLC
Nov 13, 2019 Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per c... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. Class II Precision Dose Inc.
Nov 13, 2019 Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 ma... Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. Class I Natures Rx
Nov 12, 2019 fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Pre... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuV... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Ph... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preser... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx... Discoloration; Hazy solution found in one vial instead of a clear solution. Class II AuroMedics Pharma 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.