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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

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
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 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 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 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 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
Oct 17, 2018 Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 15, 2018 Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,... Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle Class II Heritage Pharmaceuticals, Inc.
Oct 15, 2018 Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sa... Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine Class II Zero Xtreme USA
Oct 11, 2018 HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP... CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for... Class II Lannett Company, Inc.
Oct 9, 2018 Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology

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.