Category

Ophthalmic Drugs Recalls

490 ophthalmic drugs recalls on record from CPSC, FDA, and USDA.

490 recalls
RecallFDA
Lupin Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 6818...
Ophthalmic Drugs·50,832 affected·Dec 22, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 059...
Ophthalmic Drugs·66,099 affected·Dec 8, 2021
RecallFDA
Lupin Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 6818...
Ophthalmic Drugs·16,272 affected·Oct 20, 2021
High RiskFDA
Akorn, Inc.
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc.,...
Ophthalmic Drugs·10,210 affected·Oct 4, 2021
High RiskFDA
Akorn, Inc.
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A...
Ophthalmic Drugs·62,331 affected·Sep 8, 2021
High RiskFDA
Prescription Labs Inc Dba Greenpark
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Ophthalmic Drugs·350 affected·Aug 18, 2021
High RiskFDA
Anhui Welcome Foreign Trade Co.,ltd.
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)Int...
Ophthalmic Drugs·63,750 affected·Aug 12, 2021
RecallFDA
Sun Pharmaceutical Industries Inc
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactur...
Ophthalmic Drugs·0 affected·May 7, 2021
RecallFDA
Nomax Inc
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Ma...
Ophthalmic Drugs·78 affected·Apr 13, 2021
RecallFDA
Washington Homeopathic Products, Inc.
Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC ...
Ophthalmic Drugs·1,909 affected·Mar 18, 2021
High RiskFDA
Cardinal Health Inc.
TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS
Ophthalmic Drugs·325 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 1...
Ophthalmic Drugs·12 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Wort...
Ophthalmic Drugs·348 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
Ophthalmic Drugs·152 affected·Mar 15, 2021
RecallFDA
Sun Pharmaceutical Industries Inc
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactur...
Ophthalmic Drugs·37,400 affected·Feb 22, 2021
High RiskFDA
Allergan, Plc.
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, ...
Ophthalmic Drugs·100,634 affected·Dec 30, 2020
RecallFDA
Leadiant Biosciences, Inc.
Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharma...
Ophthalmic Drugs·1,380 affected·Sep 24, 2020
High RiskFDA
Akorn, Inc.
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, ND...
Ophthalmic Drugs·25,843 affected·Sep 3, 2020
High RiskFDA
Family Pharmacy Of Statesville
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Ophthalmic Drugs·3 affected·Aug 6, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206...
Ophthalmic Drugs·2 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457...
Ophthalmic Drugs·2 affected·Mar 13, 2020
High RiskFDA
Redline Pharmacy Solutions
Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings,...
Ophthalmic Drugs·2 affected·Feb 24, 2020
RecallFDA
Akorn, Inc.
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake...
Ophthalmic Drugs·33,343 affected·Dec 26, 2019
High RiskFDA
Assurance Infusion
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
Ophthalmic Drugs·32 affected·Dec 20, 2019
RecallFDA
Lupin Pharmaceuticals Inc.
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pitham...
Ophthalmic Drugs·2,130 affected·Dec 13, 2019
Medium RiskFDA
Sandoz Inc
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laborator...
Ophthalmic Drugs·346,929 affected·Oct 17, 2019
RecallFDA
Sandoz Inc
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc...
Ophthalmic Drugs·76,644 affected·Oct 17, 2019
High RiskFDA
Akorn, Inc.
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478...
Ophthalmic Drugs·60,176 affected·Sep 20, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ ...
Ophthalmic Drugs·808 affected·Sep 18, 2019
RecallFDA
Mylan Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in I...
Ophthalmic Drugs·13,157 affected·Sep 6, 2019
High RiskFDA
Compounded Solutions In Pharmacy
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Ophthalmic Drugs·6 affected·Sep 3, 2019
High RiskFDA
Compounded Solutions In Pharmacy
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
Ophthalmic Drugs·3 affected·Sep 3, 2019
High RiskFDA
Compounded Solutions In Pharmacy
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Ophthalmic Drugs·4 affected·Sep 3, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.
Ophthalmic Drugs·6 affected·Aug 12, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride ...
Ophthalmic Drugs·20,808 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoli...
Ophthalmic Drugs·25,992 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes M...
Ophthalmic Drugs·1,836 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNES...
Ophthalmic Drugs·793,872 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distri...
Ophthalmic Drugs·1,030,128 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (...
Ophthalmic Drugs·124,038 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM ...
Ophthalmic Drugs·17,316 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (G...
Ophthalmic Drugs·1,752 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. ...
Ophthalmic Drugs·1,621,200 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78...
Ophthalmic Drugs·6,661,188 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Me...
Ophthalmic Drugs·1,872,984 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF ...
Ophthalmic Drugs·314,112 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) b...
Ophthalmic Drugs·927,108 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (...
Ophthalmic Drugs·66,168 affected·Jul 26, 2019