Category
Ophthalmic Drugs Recalls
490 ophthalmic drugs recalls on record from CPSC, FDA, and USDA.
490 recalls
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 Drugs196,254 affectedOct 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 Drugs3,108 affectedOct 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 Drugs314,543 affectedOct 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 Drugs2,095,068 affectedOct 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 Drugs173,928 affectedOct 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 Drugs121,176 affectedOct 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 Drugs6,273 affectedOct 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 Drugs1,752 affectedOct 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 Drugs23,026 affectedOct 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 Drugs51,601 affectedOct 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 Drugs1,310,324 affectedOct 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 Drugs188,550 affectedOct 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 Drugs31,073 affectedOct 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 Drugs967,075 affectedOct 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 Drugs1,584 affectedOct 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 Drugs2,563 affectedOct 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 Drugs163,996 affectedOct 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 Drugs267,678 affectedOct 13, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Ophthalmic Drugs1 affectedOct 7, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 7...
Ophthalmic Drugs3,468 affectedAug 22, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ ...
Ophthalmic Drugs117,844 affectedAug 22, 2022
RecallFDA
Akorn, Inc
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Fore...
Ophthalmic Drugs5,226 affectedAug 8, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured ...
Ophthalmic Drugs7,992 affectedAug 2, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34,...
Ophthalmic Drugs8,136 affectedJul 14, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day...
Ophthalmic Drugs9 affectedJun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Steri...
Ophthalmic Drugs1 affectedJun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0...
Ophthalmic Drugs12 affectedJun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Rel...
Ophthalmic Drugs47 affectedJun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Al...
Ophthalmic Drugs12 affectedJun 29, 2022
High RiskFDA
Family Dollar Stores, Llc.
MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 901844 SYSTANE ULTRA HIGH PRFRM LUB DRPS 0.14 FLOZ SKU 9019...
Ophthalmic Drugs0 affectedJun 23, 2022
Medium RiskFDA
Novartis Pharmaceuticals Corporation
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606...
Ophthalmic Drugs279,179 affectedMay 10, 2022
Medium RiskFDA
Novartis Pharmaceuticals Corporation
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911...
Ophthalmic Drugs279,179 affectedMay 10, 2022
High RiskFDA
Novartis Pharmaceuticals Corporation
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each v...
Ophthalmic Drugs1,253,862 affectedMay 10, 2022
High RiskFDA
Novartis Pharmaceuticals Corporation
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial...
Ophthalmic Drugs1,187,092 affectedMay 10, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
Ophthalmic Drugs1 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical...
Ophthalmic Drugs799 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10
Ophthalmic Drugs1 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810
Ophthalmic Drugs44 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05
Ophthalmic Drugs50 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131435502
Ophthalmic Drugs31 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14
Ophthalmic Drugs43 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05
Ophthalmic Drugs21 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55
Ophthalmic Drugs13 affectedApr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05
Ophthalmic Drugs7 affectedApr 13, 2022
High RiskFDA
Mylan Pharmaceuticals Inc
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, ...
Ophthalmic Drugs20,112 affectedApr 1, 2022
RecallFDA
Sun Pharmaceutical Industries Inc
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun ...
Ophthalmic Drugs73,030 affectedApr 1, 2022
High RiskFDA
Direct Rx
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma U...
Ophthalmic Drugs44 affectedFeb 17, 2022
High RiskFDA
Aurobindo Pharma Usa Inc.
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, ...
Ophthalmic Drugs115,776 affectedJan 14, 2022