Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
www.fda.gov →Official Site

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68,659 recalls
High RiskFDA
Getinge Usa Sales Inc
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Medical Devices·5 affected·Oct 14, 2022
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue b...
Surgical Devices·95 affected·Oct 14, 2022
High RiskFDA
Sonendo Inc
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Medical Devices·15 affected·Oct 14, 2022
High RiskFDA
Sonendo Inc
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Medical Devices·16 affected·Oct 14, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food·15,865,104 affected·Oct 13, 2022
CriticalFDA
Hammond's Candies Since 1920 Ii, Llc
Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6 91355 89889 5, Manufactured for: Hammond's Candies, 5735 Washington St, Denv...
Bakery & Grains·216 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Beverages·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by...
Ophthalmic Drugs·91,692 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 1747...
Drugs·2,369,258 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: M...
Ophthalmic Drugs·65,006 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examination...
Ophthalmic Drugs·196,254 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Ophthalmic Drugs·3,108 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 174...
Ophthalmic Drugs·314,543 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 1...
Ophthalmic Drugs·2,095,068 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 1...
Ophthalmic Drugs·173,928 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ND...
Topical Drugs·524,506 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed b...
Ophthalmic Drugs·121,176 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, In...
Topical Drugs·36,455 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lak...
Ophthalmic Drugs·6,273 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn,...
Ophthalmic Drugs·1,752 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045...
Ophthalmic Drugs·23,026 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Ako...
Topical Drugs·2,082 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: ...
Ophthalmic Drugs·51,601 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured ...
Topical Drugs·36,025 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60...
Topical Drugs·1,109,600 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17...
Ophthalmic Drugs·1,310,324 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-2...
Ophthalmic Drugs·188,550 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ...
Ophthalmic Drugs·31,073 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest...
Topical Drugs·1,164,171 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn,...
Ophthalmic Drugs·967,075 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL...
Ophthalmic Drugs·1,584 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 1747...
Ophthalmic Drugs·2,563 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn,...
Ophthalmic Drugs·163,996 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC...
Ophthalmic Drugs·267,678 affected·Oct 13, 2022
RecallFDA
Aadi Bioscience
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for ...
Injectable Drugs·2,333 affected·Oct 13, 2022
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultativ...
Medical Devices·13,900 affected·Oct 13, 2022
High RiskFDA
Boston Scientific Corporation
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Medical Devices·16 affected·Oct 13, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 ....
Diagnostic Devices·17,396 affected·Oct 13, 2022
High RiskFDA
Medical Action Industries, Inc. 306
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, R...
Medical Devices·24 affected·Oct 12, 2022