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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

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Jul 14, 2023 norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Cent... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, R... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 13, 2023 Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bot... Presence of Foreign Substance: Metal embedded in a tablet. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 13, 2023 Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil... Lack of Assurance of Sterility Class II New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Jul 11, 2023 Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For I... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals
Jul 11, 2023 Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Jul 11, 2023 Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals
Jul 11, 2023 Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, la... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals
Jul 10, 2023 Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Ph... Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 10, 2023 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Com... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, A... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic... CGMP Deviation: impurities exceed allowable limits. Class II Tenn South Distillery LLC dba Big Machine Disti...
Jul 10, 2023 PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 7, 2023 Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 m... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 m... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 ... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 5, 2023 Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured B... Failed Moisture Limits: Water (moisture) content above the approved product specifications. Class II Teva Pharmaceuticals USA Inc
Jul 5, 2023 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... Lack of assurance of sterility: bags have the potential to leak. Class II B. Braun Medical Inc.
Jul 3, 2023 Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl... Presence of Particulate Matter: Particulate matter identified as fiber. Class II Accord Healthcare, Inc.
Jul 3, 2023 Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured... Presence of Particulate Matter: Particulate matter identified as fiber. Class II Accord Healthcare, Inc.
Jun 26, 2023 Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, ... Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. Class II Strides Pharma Inc.
Jun 26, 2023 Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 687... Failed Stability Specifications Class II Preferred Pharmaceuticals, Inc.
Jun 23, 2023 Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), pac... CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class II Kramer Laboratories, Inc.
Jun 23, 2023 Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ... Class II Amerisource Health Services LLC
Jun 23, 2023 Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppress... CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class II Kramer Laboratories, Inc.
Jun 22, 2023 Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles... Defective Delivery System Class II ALEMBIC PHARMACEUTICALS, INC.
Jun 21, 2023 Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr.... Failed dissolution specification: Out of specification results observed in 24-month long term sta... Class II Dr Reddy's Laboratories Limited
Jun 16, 2023 Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl... Packaging defect: blister packaging inadequately sealed. Class II The Harvard Drug Group
Jun 13, 2023 Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 13, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 12, 2023 Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 va... cGMP deviations: potential for Microbial Contamination of Non-Sterile Products Class II Ferring Pharmaceuticals Inc
Jun 5, 2023 Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New Y... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: Ste... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distribu... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distribute... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distr... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distr... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Ge... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaL... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufa... cGMP deviations Class II Homeocare Laboratories, 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.