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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

1,327 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,327 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 1,327 FDA drug recalls in IL.

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DateProductReasonClassFirm
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.
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.

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.