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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

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
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) Class II Hikma Pharmaceuticals USA Inc.
Dec 16, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx o... Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of th... Class II Akorn Inc
Dec 13, 2019 RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA ND... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Granules India Limited
Dec 11, 2019 Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repac... CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts a... Class II RemedyRepack Inc.
Dec 11, 2019 Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronize... Subpotent Drug: Supplier indicated assay results did not meet specifications. Class II Spectrum Laboratory Products
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 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 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 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 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 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 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 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 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 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 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 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 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
Nov 12, 2019 fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Pres... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inha... Lack of Processing Controls Class II Integrated Health Concepts Inc. dba Conversio H...
Nov 12, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversi... Lack of Processing Controls Class II Integrated Health Concepts Inc. dba Conversio H...

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.