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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

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Jul 14, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 9, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the pa... Class II CareFusion 213, LLC
Jul 6, 2026 CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Sing... Lack of Assurance of Sterility Class II Chiesi USA, Inc.
Jun 24, 2026 Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, Fo... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intraven... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 11, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopr... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropy... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v is... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 10, 2026 IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Singl... Lack of assurance of Sterility: Class II ACCORD BIOPHARMA INC
Jun 8, 2026 Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only,... Lack of Assurance of Sterility Class II Asclemed USA Inc.
Jun 8, 2026 Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL sin... Lack of Assurance of Sterility Class II Asclemed USA Inc.
May 28, 2026 BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility:... Class I CareFusion 213, LLC
May 28, 2026 BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-Sterility: Due to presence of Aspergillus penicillioides. Class I CareFusion 213, LLC
May 28, 2026 BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
May 28, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
May 18, 2026 PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PR... Lack of Assurance of Sterility Class II PReye LLC
May 12, 2026 Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distribut... Lack of Assurance of Sterility Class II Spectra Medical Devices, Llc
May 8, 2026 cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), R... Lack of Assurance of Sterility Class II UCB Biosciences Inc.
Apr 27, 2026 Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle... Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution foll... Class II Oasis Medical, Inc.
Apr 24, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Apr 23, 2026 iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea Pharma, Inc.
Apr 23, 2026 Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (1... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea Pharma, Inc.
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 21, 2026 Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in F... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research LLC
Apr 21, 2026 GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: ... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research LLC
Apr 20, 2026 Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile... Lack of Assurance of Sterility Class II SCOPE HEALTH
Apr 17, 2026 FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nas... Lack of Assurance of Sterility Class II Harrow Eye LLC
Apr 6, 2026 DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II Fresenius Medical Care Holdings, Inc.
Apr 6, 2026 DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II Fresenius Medical Care Holdings, Inc.
Apr 2, 2026 Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Via... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials,... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL)... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Pre... Lack of Assurance of Sterility Class II Huons Co., Ltd.

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.