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Vehicle Safety

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

Consumer Safety

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

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Nov 2, 2018 IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
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 Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactur... Cross Contamination with Other Products Class II Sandoz Inc
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
Nov 1, 2018 Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Sandoz, Inc
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
Oct 31, 2018 BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in n... Lack of Assurance of Sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 29, 2018 Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Ph... CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... Class II Westminster Pharmaceuticals Llc
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 29, 2018 GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen P... CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... Class II Westminster Pharmaceuticals Llc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen P... CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... Class II Westminster Pharmaceuticals Llc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-11... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in... Defective Container: vial defect was identified that could potentially impact the container closu... Class II GE Healthcare Inc. Life Sciences
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30),... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured b... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 26, 2018 Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8... CGMP Deviations: Product was released to market prior to microbiological testing. Class II S.C. Johnson Professional
Oct 26, 2018 Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... Class III RemedyRepack Inc.
Oct 26, 2018 deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl.... CGMP Deviations: Product was released to market prior to microbiological testing. Class II S.C. Johnson Professional
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 24, 2018 Irbesartan Bulk Active Pharmaceutical Ingredient. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... Class II Aurobindo Pharma Limited (Unit I)
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 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 22, 2018 Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: OOS resultsduring routine stability testing Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 19, 2018 Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIS... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Ave... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, R... Failed dissolution specifications: Out-of-Specification dissolution test result obtained during r... Class II Teva Pharmaceuticals USA
Oct 19, 2018 Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 18, 2018 Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bott... Presence of precipitate Class III Promise Pharmacy LLC
Oct 18, 2018 GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg... Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 mont... Class II H J Harkins Company Inc dba Pharma Pac
Oct 17, 2018 Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (ND... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-0... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 c... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-1... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-18... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-11... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06)... Lack of Assurance of Sterility Class II Qualgen, 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.