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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

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.

Clear
DateProductReasonClassFirm
Apr 3, 2018 Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04 Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vit... Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Botox 100 Units Vial NDC 00023-1145-01 90 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Ibrance 125 mg cap NDC 00069-0189-21 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 2, 2018 WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dis... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Apr 2, 2018 ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Mar 30, 2018 PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 g... Microbial Contamination of Non-Sterile Products Class II Marcas Usa Llc
Mar 30, 2018 Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,... Failed Dissolution Specifications Class II AVKARE Inc.
Mar 29, 2018 Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC ... CGMP Deviations: the product was produced with substandard GMP manufacturing processes. Class II United Pacific Co Ltd
Mar 28, 2018 Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), El... cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, M... cGMP Deviations Class II Elroselabs Inc.
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL pack... Superpotent Drug Class II Lupin Pharmaceuticals Inc.
Mar 27, 2018 Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administratio... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 22, 2018 Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specia... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL a... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 583... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Speci... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy

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.