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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

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C;... cGMP Deviations Class II Family Medical Supply Inc
Nov 9, 2023 VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 7, 2023 Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Nov 7, 2023 Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, R... Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules Class II Padagis US LLC
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Oct 27, 2023 Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distribute... Failed Dissolution Specifications Class II Amneal Pharmaceuticals of New York, LLC
Oct 23, 2023 Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Ma... Failed Dissolution Specifications: Out of specification for dissolution. Class II Glenmark Pharmaceuticals Inc., USA
Oct 20, 2023 DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4... Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... Class II Omega & Delta Co., Inc.
Oct 20, 2023 Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 ... Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... Class II Omega & Delta Co., Inc.
Oct 20, 2023 Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Man... Failed Dissolution Specifications Class II Glenmark Pharmaceuticals Inc., USA
Oct 20, 2023 Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distrib... Failed Impurities/Degradation Specifications. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 20, 2023 DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237... Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... Class II Omega & Delta Co., Inc.
Oct 20, 2023 Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottle... Failed Viscosity Specifications: Out-of-specification test results for viscosity Class II ITF PHARMA INC
Oct 20, 2023 Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distribu... Failed Impurities/Degradation Specifications. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 19, 2023 Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx... Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... Class II Zydus Pharmaceuticals (USA) Inc
Oct 19, 2023 Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx ... Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... Class II Zydus Pharmaceuticals (USA) Inc
Oct 19, 2023 Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx... Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... Class II Zydus Pharmaceuticals (USA) Inc
Oct 19, 2023 Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dro... CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. Class II Safecor Health, LLC
Oct 18, 2023 Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Sc... CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... Class II Integrity Bio-Chemicals LLC
Oct 18, 2023 Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla ... CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... Class II Integrity Bio-Chemicals LLC
Oct 18, 2023 Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender ... CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... Class II Integrity Bio-Chemicals LLC
Oct 13, 2023 Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distribute... Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast S... Class II Dr. Reddy's Laboratories, Inc.
Oct 5, 2023 Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail sto... CGMP Deviations: OTC products were stored outside of labeled temperature requirements. Class II Dollar Tree Distribution, Inc.
Oct 4, 2023 Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ing... CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and release... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 2, 2023 Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL mult... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx o... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compo... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 6... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalm... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL s... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, R... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal adminis... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Co... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Sta... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, 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.