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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

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Aug 20, 2021 Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, W... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 4064... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 20, 2021 Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Ma... Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class II Washington Homeopathic Products, Inc.
Aug 19, 2021 Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only,... Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL act... Class II Eli Lilly & Company
Aug 19, 2021 Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Mark... Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/2... Class II Rhodes Pharmaceuticals, L.P.
Aug 18, 2021 Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Green... Lack of Assurance of Sterility Class II Prescription Labs Inc dba Greenpark
Aug 18, 2021 X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 1368... Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Class I Phe Inc
Aug 17, 2021 Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pen... A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product w... Class II RemedyRepack Inc.
Aug 13, 2021 GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compound... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laborator... Failed Impurities Specifications: Out of Specification impurity results obtained during routine t... Class II SigmaPharm Laboratories LLC
Aug 13, 2021 TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compoundin... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 m... Failed impurities/degradation specification: Out of Specification for an unknown impurity observe... Class II Akorn, Inc.
Aug 13, 2021 ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by:... Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle Class II Zydus Pharmaceuticals (USA) Inc
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfi... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compound... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...

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.