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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

1,317 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,317 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 1,317 FDA drug recalls in IL.

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DateProductReasonClassFirm
Aug 17, 2020 Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 17, 2020 Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Jul 22, 2020 Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m... Cross Contamination with other products: trace amounts of lidocaine Class I Fresenius Kabi USA, LLC
Jul 13, 2020 Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on... Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta... Class III Fresenius Kabi USA, LLC
Jul 7, 2020 Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma... Presence of Particulate Matter Class I Mylan Institutional LLC
Jun 5, 2020 Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx onl... Discoloration: Out of Specification (OOS) result for APHA Color Test. Class III Akorn, Inc.
May 8, 2020 LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matt... Class I ICU Medical Inc
May 5, 2020 Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,... Discoloration: Out-of-specification results for appearance obtained during routine stability test... Class II Mylan Institutional LLC
Apr 20, 2020 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... Presence of Particulate Matter - found in reserve sample vials at the firm. Class II Fresenius Kabi USA, LLC
Apr 20, 2020 Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... Presence of Particulate Matter - found in reserve sample vials at the firm. Class I Fresenius Kabi USA, LLC
Mar 25, 2020 Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per car... Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.... Class III Akorn Inc
Feb 21, 2020 Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Feb 21, 2020 CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distribu... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Feb 21, 2020 Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, D... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Dec 26, 2019 Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ... Chemical contamination; out of specification results obtained for equipment cleaning residue rins... Class III Akorn, Inc.
Dec 16, 2019 NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx o... Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of th... Class II Akorn Inc
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Nov 19, 2019 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare... Lack of Assurance of Sterility: Product has the potential to leak. Class II Baxter Healthcare Corporation
Nov 15, 2019 MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3... Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP ... Class II Akorn, Inc.
Nov 13, 2019 Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per c... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. Class II Precision Dose Inc.
Oct 25, 2019 LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical Inc
Oct 25, 2019 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical 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 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.
Aug 6, 2019 Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo... Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) an... Class III Akorn, Inc.
Aug 6, 2019 Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 1... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as... Class III Akorn, Inc.
Aug 6, 2019 Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as... Class III Akorn, Inc.
Jul 18, 2019 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter... Lack of Assurance of Sterility: Bags have potential to leak. Class II Baxter Healthcare Corporation
Jun 28, 2019 Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 ... Presence of Particulate Matter; glass particulates Class I Fresenius Kabi USA, LLC
Jun 13, 2019 Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... Failed Stability Specifications Class II Baxter Healthcare Corporation
Jun 7, 2019 Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu... Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar... Class III Akorn Inc
Apr 30, 2019 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL V... Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufac... Class II Sagent Pharmaceuticals Inc
Apr 23, 2019 Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car... Failed impurities/degradation specification: Out of Specification result for total impurity at 4.... Class III Akorn Inc
Mar 28, 2019 Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on... Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob... Class III Akorn, Inc.
Mar 26, 2019 Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/... Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufact... Class III Medi-Physics Inc. dba GE Healthcare
Mar 12, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, ... Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testi... Class II Akorn Inc
Feb 22, 2019 Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manu... Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individ... Class II Akorn, Inc.
Feb 4, 2019 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos... CGMP Deviations Class II ICU Medical Inc
Feb 4, 2019 Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl... Failed Stability Specification: out of specification results for Sodium Perborate Class II Akorn Inc
Feb 1, 2019 Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx... Presence of Particulate Matter: particulate matter identified as copper salts Class I Mylan Institutional Inc
Jan 25, 2019 Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an... Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ... Class III Akorn Inc
Jan 18, 2019 Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for... Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected durin... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 2, 2019 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. Class II Baxter Healthcare Corporation
Dec 20, 2018 COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ... Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit... Class III Akorn Inc
Dec 5, 2018 Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in... Sub-potent Class II Pharmedium Services, LLC
Dec 5, 2018 Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% i... Sub-potent Class II Pharmedium Services, LLC
Nov 6, 2018 AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:... Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ... Class III Takeda Development Center Americas, 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.