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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

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

23 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 23 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 23 FDA drug recalls.

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DateProductReasonClassFirm
Aug 11, 2026 Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, R... Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified ... Class I American Regent, Inc.
Jul 24, 2026 Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose ... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged i... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, p... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 m... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL via... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packa... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT F... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Sing... Presence of Particulate Matter: Product contaminated with particulate matter identified as glass ... Class I American Regent, Inc.
Jul 24, 2026 ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT F... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC U... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Apr 16, 2026 Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, Fo... Labeling: Missing Label Class III American Regent, Inc.
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
May 14, 2024 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL... Lack of Assurance of Sterility. Class II American Regent, Inc.
May 13, 2024 Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Mult... Subpotent product in addition to having out-of-specification results for impurities. Class II American Regent, Inc.
Apr 24, 2012 Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and I... Presence of Particulate Matter Class II Luitpold Pharmaceuticals, Inc.
Mar 15, 2011 CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL... Presence of Particulate Matter: In the course of inspecting retention samples visual particles w... Class II Luitpold Pharmaceuticals, Inc.

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.