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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

2,012 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,012 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 2,012 FDA drug recalls.

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DateProductReasonClassFirm
Mar 5, 2019 LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containi... Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approve... Class I USA LESS Inc.
Feb 8, 2019 MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use ... Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... Class II Avella of Deer Valley, Inc. Store 38
Feb 8, 2019 MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use b... Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... Class II Avella of Deer Valley, Inc. Store 38
Feb 8, 2019 Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL sin... Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... Class II Avella of Deer Valley, Inc. Store 38
Feb 8, 2019 MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Com... Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... Class II Avella of Deer Valley, Inc. Store 38
Feb 7, 2019 Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Labo... Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. Class III ACP Nimble Buyer, Inc.
Feb 6, 2019 Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of... Labeling: Incorrect expiration date. Class II Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Jan 24, 2019 LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), ... Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date an... Class II US Compounding Inc
Jan 16, 2019 NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 16, 2019 NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 16, 2019 Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards,... Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate S... Class II Rx Pak Division of McKesson Corporation
Jan 15, 2019 HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodiu... Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/5... Class II Advanced Pharma Inc.
Jan 15, 2019 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Jan 15, 2019 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Jan 15, 2019 infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Dec 26, 2018 LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC... Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i... Class III Sun Pharmaceutical Industries, Inc.
Dec 11, 2018 Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: K... Labeling: Wrong bar code Class II KVK-Tech, Inc.
Dec 11, 2018 Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 11, 2018 Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 10, 2018 Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o... Superpotent Drug: contains higher levels of Iron than labeled. Class II Gordon Laboratories
Nov 29, 2018 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So... Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per ... Class I Advanced Pharma Inc.
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 9, 2018 Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Nov 9, 2018 Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl o... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Nov 8, 2018 ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use v... Labeling: Missing label; potential for missing primary container label on the vial. Class III Eli Lilly & Co
Nov 2, 2018 curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Ep... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 ... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarn... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contai... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 1, 2018 Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe... Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May... Class III Bound Tree Medical, LLC
Nov 1, 2018 curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains... Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 e... Class II Bound Tree Medical, LLC
Oct 26, 2018 Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), F... Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and ... Class I Dr. Reddy's Laboratories, Inc.
Oct 23, 2018 Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg,... Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont... Class II Janssen Pharmaceuticals, Inc.
Oct 23, 2018 Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28... Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont... Class II Janssen Pharmaceuticals, Inc.
Oct 3, 2018 Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g T... Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Hep... Class II Pfizer Inc.
Sep 28, 2018 Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Su... Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration dat... Class II Tailor Made Compounding
Sep 25, 2018 Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pi... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top p... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 18, 2018 Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 m... Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging com... Class III Xiromed LLC
Sep 17, 2018 treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for... Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel... Class III Otsuka Pharmaceutical Development & Commerciali...
Sep 17, 2018 treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for ... Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel... Class III Otsuka Pharmaceutical Development & Commerciali...
Sep 17, 2018 robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ... Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly... Class I Endo Pharmaceuticals, Inc.
Aug 27, 2018 Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3... Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. Class III Mylan Pharmaceuticals Inc.
Aug 23, 2018 Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL O... Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the i... Class II Pfizer Global Supply

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.