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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

18,041 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,041 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 18,041 FDA drug recalls.

DateProductReasonClassFirm
Sep 24, 2019 Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 23, 2019 Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manu... Superpotent Class II Macleods Pharma Usa Inc
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactur... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp,... CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles... Class III AuroMedics Pharma LLC
Sep 23, 2019 DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 23, 2019 DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactur... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactu... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl o... Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 Class II Morton Grove Pharmaceuticals, Inc.
Sep 20, 2019 Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx ... Lack of Assurance of Sterility: Out of specification results for container closure test which can... Class II Akorn, Inc.
Sep 19, 2019 Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate... Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for wei... Class II Aurobindo Pharma USA Inc.
Sep 19, 2019 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets ... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 19, 2019 Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manuf... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 19, 2019 Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx O... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 19, 2019 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets p... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 18, 2019 Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30... Microbial Contamination of Non-Sterile Product. Class II GCP Laboratories Inc
Sep 18, 2019 Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: ... Lack of sterility assurance. Class II Avella of Deer Valley, Inc. Store 38
Sep 17, 2019 Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufac... cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tub... Class II Akorn, Inc.
Sep 16, 2019 Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2... Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Class I FITOTERAPIA USA, INC
Sep 13, 2019 Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefille... Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... Class III GUERBET LLC
Sep 13, 2019 Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, pac... Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... Class II GUERBET LLC
Sep 12, 2019 Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single D... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL)... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnolog... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fi... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 12, 2019 GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syr... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Par... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartri... Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... Class I Shire Human Genetic Therapies, Inc.
Sep 12, 2019 SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL S... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fi... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Onl... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injection... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartri... Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... Class I Shire Human Genetic Therapies, Inc.
Sep 12, 2019 Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Sin... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global B... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Glo... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG... CGMP Deviations: Received notice from supplier that there is potential glass contamination. Class II Spectrum Laboratory Products
Sep 12, 2019 L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC... Lack of Assurance of Sterility Class II KRS Global Biotechnology, 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.