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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.

Clear
DateProductReasonClassFirm
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 27, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... Failed Dissolution Specification: Out of specification dissolution results at time point zero. Th... Class II Amerisource Health Services LLC
Jan 17, 2023 Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 ... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 17, 2023 Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 17, 2023 Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 M... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Urban Electric Power
Jan 17, 2023 Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Urban Electric Power
Jan 16, 2023 Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord He... Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a... Class II Preferred Pharmaceuticals, Inc.
Jan 13, 2023 Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 13, 2023 S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Ste... Short Fill Class II Nephron Sc Inc
Jan 13, 2023 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine,... Short Fill Class II Nephron Sc Inc
Jan 12, 2023 Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for:... Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack t... Class II Accord Healthcare, Inc.
Jan 12, 2023 Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Jan 12, 2023 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Onl... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Jan 11, 2023 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 10... Failed Dissolution Specifications: This recall is being initiated in support of the recall by the... Class II Amerisource Health Services LLC
Jan 10, 2023 Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle... CGMP Deviations: initiated due to violations of CGMP manufacturing practices Class II Consolidated Chemical, Inc
Jan 10, 2023 Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Sai... CGMP Deviations: initiated due to violations of CGMP manufacturing practices Class II Consolidated Chemical, Inc
Jan 6, 2023 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syri... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Dec 30, 2022 TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials,... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTAB... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial,... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECT... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 29, 2022 Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium... Lack of assurance of sterility: Bags have the potential to leak. Class II Pfizer Inc.
Dec 28, 2022 Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL V... Presence of Particulate Matter: Customer complaint of dark particles found inside the vial Class II Eugia US LLC
Dec 28, 2022 Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 678... Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on th... Class II Ascend Laboratories, LLC
Dec 27, 2022 ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services,... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Hom... Lack of sterility assurance Class II Sentara Infusion Services

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.