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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

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

10 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 10 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 10 FDA drug recalls.

Clear
DateProductReasonClassFirm
Dec 22, 2016 Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratori... Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. Class II Roxane Laboratories, Inc.
Dec 14, 2016 Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spra... Defective Delivery System: out of specification result for droplet size distribution at the d90 m... Class III Roxane Laboratories, Inc.
Oct 6, 2016 DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane ... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Sep 25, 2015 FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... Class III Boehringer Ingelheim Roxane Inc
Sep 25, 2015 FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... Class III Boehringer Ingelheim Roxane Inc
Apr 2, 2015 Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co... Subpotent Drug: The firm received an out of specification result for Assay (potency was below spe... Class II Boehringer Ingelheim Roxane Inc
Jul 28, 2014 OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl... Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Class III Boehringer Ingelheim Roxane Inc
May 1, 2014 Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories,... Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at... Class II Boehringer Ingelheim Roxane Inc
Apr 3, 2013 Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringe... Resuspension Problems: Recalled lot did not meet resuspendability requirements. Class II Boehringer Ingelheim Roxane Inc
Mar 18, 2013 Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets... SubPotent Drug: The firm discovered out of specification results for assay and the extended inves... Class III Boehringer Ingelheim Roxane 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.