Category
Ophthalmic Drugs Recalls
490 ophthalmic drugs recalls on record from CPSC, FDA, and USDA.
490 recalls
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs362,544 affectedJul 18, 2024
High RiskFDA
Imprimis Njof, Llc
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimi...
Ophthalmic Drugs4,280 affectedMay 14, 2024
High RiskFDA
Imprimis Njof, Llc
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OF...
Ophthalmic Drugs136,005 affectedMay 14, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), R...
Ophthalmic Drugs382,104 affectedApr 25, 2024
RecallFDA
Sun Pharmaceutical Industries Inc
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., In...
Ophthalmic Drugs35,069 affectedApr 22, 2024
High RiskFDA
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 str...
Ophthalmic Drugs15,056 affectedApr 19, 2024
High RiskFDA
Nomax Inc
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 600...
Ophthalmic Drugs15,444 affectedApr 19, 2024
High RiskFDA
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis,...
Ophthalmic Drugs6,960 affectedApr 19, 2024
High RiskFDA
Nomax Inc
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, I...
Ophthalmic Drugs4,648 affectedApr 19, 2024
High RiskFDA
Imprimis Njof, Llc
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC...
Ophthalmic Drugs3,320 affectedApr 10, 2024
High RiskFDA
Thea Pharma, Inc.
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Ophthalmic Drugs5,476 affectedMar 5, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 2...
Ophthalmic Drugs24,216 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi ...
Ophthalmic Drugs30,240 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi L...
Ophthalmic Drugs19,344 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite #...
Ophthalmic Drugs10,536 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lan...
Ophthalmic Drugs106,704 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite...
Ophthalmic Drugs9,936 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Ren...
Ophthalmic Drugs7,248 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi La...
Ophthalmic Drugs139,656 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 20...
Ophthalmic Drugs47,832 affectedFeb 29, 2024
High RiskFDA
Optikem International, Inc.
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Ri...
Ophthalmic Drugs46,621 affectedFeb 29, 2024
CriticalFDA
Kilitch Healthcare India Limited
Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity ...
Ophthalmic Drugs2,820 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76...
Ophthalmic Drugs386,256 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Sing...
Ophthalmic Drugs401,568 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by:...
Ophthalmic Drugs45,408 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by:...
Ophthalmic Drugs56,520 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio ...
Ophthalmic Drugs14,784 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunt...
Ophthalmic Drugs6,024 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) a...
Ophthalmic Drugs137,784 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bot...
Ophthalmic Drugs33,984 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-...
Ophthalmic Drugs210,192 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livo...
Ophthalmic Drugs1,492,344 affectedNov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter L...
Ophthalmic Drugs7,296 affectedNov 13, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distribute...
Ophthalmic Drugs28,477 affectedOct 31, 2023
CriticalFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC ...
Ophthalmic Drugs1,271,810 affectedOct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, ...
Ophthalmic Drugs8,784 affectedOct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardin...
Ophthalmic Drugs119,871 affectedOct 31, 2023
CriticalFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, ...
Ophthalmic Drugs65,880 affectedOct 31, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawan...
Ophthalmic Drugs1,598 affectedOct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Phar...
Ophthalmic Drugs1,693 affectedOct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Ton...
Ophthalmic Drugs128 affectedOct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 3...
Ophthalmic Drugs662 affectedOct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuti...
Ophthalmic Drugs2,181 affectedOct 2, 2023
RecallFDA
Imprimis Njof, Llc
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle...
Ophthalmic Drugs6,228 affectedSep 20, 2023
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 Drugs69,707 affectedSep 7, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Com...
Ophthalmic Drugs8,747 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceutica...
Ophthalmic Drugs30,490 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs196,442 affectedSep 1, 2023