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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
Oct 29, 2018 Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 ple... Failed Impurities/Degradation Specifications; out of specification results observed for other ind... Class III Akorn, Inc.
Oct 15, 2018 Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile si... Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the imp... Class III Baxter Healthcare Corporation
Oct 8, 2018 Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Onl... Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. Class II Akorn, Inc.
Oct 8, 2018 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Oct 8, 2018 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Sep 25, 2018 Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Sep 17, 2018 SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g t... Microbial Contamination of Non-Sterile Product Class II Medline Industries Inc
Sep 10, 2018 Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 1... Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes o... Class II Takeda Development Center Americas, Inc.
Sep 6, 2018 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare ... cGMP Deviation Class II Baxter Healthcare Corporation
Aug 24, 2018 Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For... Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified ... Class II Akorn, Inc.
Aug 21, 2018 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 14, 2018 Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c... Failed Impurities/Degradation Specifications; out of specification results for related compound p... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Aug 8, 2018 Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle... Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-... Class III Akorn, Inc.
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Aug 1, 2018 Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... Class II Akorn, Inc.
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% D... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Jul 24, 2018 Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bot... Defective Container: Tamper Evident foil seal not completely intact. Class II Morton Grove Pharmaceuticals, Inc.
Jul 17, 2018 Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochloroth... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochloroth... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 3, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: The manufacturer of this product recalled because they were not manufactured und... Class II Medgyn Products, Inc.
Jun 28, 2018 Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per... Microbial Contamination of Sterile Products: Product associated with reports of adverse events in... Class II PFIZER
Jun 22, 2018 Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by ... CGMP Deviations Class II Akorn, Inc.
Jun 4, 2018 Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Si... Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. Class I HOSPIRA INC, LAKE FOREST
May 31, 2018 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, I... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 22, 2018 READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloth... Microbial Contamination of a Non-Sterile Product. Class II Medline Industries Inc (Northpoint Services)
May 1, 2018 Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018 Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Apr 10, 2018 Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ... cGMP deviations Class III Pharmedium Services, LLC
Mar 29, 2018 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-72... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 9, 2018 Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by:... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class III Akorn, Inc.
Mar 9, 2018 Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... Class III Alva-Amco Pharmacal Companies., Inc.
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Sing... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Feb 21, 2018 Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... Failed Stability Specification: OOS low viscosity results discovered during retain testing. Class III Akorn, Inc.
Feb 15, 2018 PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodi... Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. Class II Medline Industries Inc
Jan 22, 2018 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... Labeling: Label Error on Declared Strength Class II Astellas Pharma US Inc
Jan 22, 2018 Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by... Defective container: presence of a hole in the liners of the caps covering the product bottle, in... Class III AbbVie Inc.
Jan 16, 2018 Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K... Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related ... Class III Fresenius Kabi USA, LLC
Dec 27, 2017 Ropivacaine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC

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.