PlainRecalls

Search Recalls

Search our full database of product recalls from FDA, CPSC, NHTSA, and USDA. Find recalls by product name, brand, manufacturer, hazard type, or keyword.

PlainRecalls indexes tens of thousands of recall records across multiple federal agencies. Use the search box below to find specific products or browse by agency, category, or date on the respective listing pages. Search results include the recall title, the recalling firm, severity classification, and the date the recall was announced.

Found 21 recalls matching "ketorolac ophthalmic"

FDA Drug Moderate Dec 17, 2025

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use …

Fagron Compounding Services

FDA Drug Moderate Oct 8, 2025

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manu…

Apotex Corp.

FDA Drug Low Jul 30, 2025

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF,…

Imprimis NJOF, LLC

FDA Drug Moderate Jul 2, 2025

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: …

Apotex Corp.

FDA Drug Low Apr 9, 2025

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LL…

Imprimis NJOF, LLC

FDA Drug Low Dec 6, 2023

Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Us…

Fagron Compounding Services

FDA Drug Low Oct 25, 2023

MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, …

Imprimis NJOF, LLC

FDA Drug Moderate Jun 7, 2023

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (…

Akorn, Inc.

FDA Drug Moderate Feb 2, 2022

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose D…

Edge Pharma, LLC

FDA Drug Moderate Feb 2, 2022

Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, F…

Edge Pharma, LLC

FDA Drug Moderate Feb 2, 2022

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, …

Edge Pharma, LLC

FDA Drug Moderate Oct 9, 2019

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Oph…

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Dropta…

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.…

KRS Global Biotechnology, Inc

FDA Drug Moderate Feb 20, 2019

Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31…

Promise Pharmacy, LLC

FDA Drug Moderate Jan 17, 2018

Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global…

KRS Global Biotechnology, Inc

FDA Drug Moderate Jan 17, 2018

Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biot…

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 5, 2016

Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial…

Pharmacy Plus, Inc. dba Vital Care Compounder

FDA Drug Moderate Mar 4, 2015

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Dr…

Sun Pharma Global Fze

FDA Drug Moderate Aug 22, 2012

CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT)

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

How PlainRecalls Search Works

The search tool on this page lets you query the full PlainRecalls dataset by name, location, identifier, or any supported field. We index every record at ingestion time so typical queries return in well under a second, even on large result sets. Matching is tolerant of partial input and common misspellings — you can type a last name, a city, a bar or license number, or any fragment of a record title. If you get no results, try broadening the query or using a shorter prefix.

What Happens Behind the Search Box

Every search queries our read-only mirror of the upstream public-record dataset. We refresh the mirror on a scheduled cadence — check the methodology page for the current source freshness window — and we do not modify the underlying records, only normalize formatting (title case, trimmed whitespace, standardized state codes) so that search results are consistent across records with different upstream spellings. Results link directly to the full record page, where you will see the complete regulated data plus plain-language explainers that describe what each field means.

Responsible Use of Search Results

Information surfaced here is drawn from public sources, but individual records can contain clerical errors, may lag real-world changes, or may be incomplete for historical reasons. Before making any consequential decision — legal, medical, financial, employment, safety-related — you should verify the underlying fact directly with the issuing agency. PlainRecalls does not render professional advice, does not rank or endorse individual records, and does not accept paid placement. We surface public data faithfully and explain it in clear language; how you act on the information is your responsibility and, when the stakes are high, the responsibility of a licensed professional you consult.

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