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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

14,483 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,483 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 14,483 FDA drug recalls, Class II.

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DateProductReasonClassFirm
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chlor... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 m... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 2... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Me... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 4, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... Failed Impuities/Degradation Specifications Class II Fresenius Kabi USA, LLC
May 4, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... Failed Impuities/Degradation Specifications Class II Fresenius Kabi USA, LLC
Apr 29, 2016 3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifesty... Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Class II Making It a Lifestyle
Apr 28, 2016 Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administra... Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray can... Class II Lymol Medical
Apr 28, 2016 Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distribu... Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. Class II Pfizer Inc.
Apr 27, 2016 Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled ... Defective Delivery System; may have a low frequency assembly fault which may result in pens block... Class II Novo Nordisk Inc
Apr 27, 2016 Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-3... Lack of Assurance of Sterility: Due to potential for leaking bags. Class II Teva North America
Apr 25, 2016 Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Do... Presence of Particulate Matter: Glass particulate found in sterile injectable product Class II Fresenius Kabi USA, LLC
Apr 20, 2016 Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PA... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARM... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Mono... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a ... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, U... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx O... Lack of Assurance of Sterility Class II Pharmakon 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.