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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

6,322 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,322 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 6,322 FDA drug recalls.

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DateProductReasonClassFirm
Aug 12, 2019 S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S071720... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Ph... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Col... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Coloni... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, an... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx onl... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 I... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 18, 2019 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter... Lack of Assurance of Sterility: Bags have potential to leak. Class II Baxter Healthcare Corporation
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 ... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 2, 2019 Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Oph... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 P... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50 Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manu... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, 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.