CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac recalled

Edge Pharma is recalling Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes11-2021-02@2 12/16/2021

Quantity recalled40 droptainers

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0422-2022
FDA event ID: 89172
Recalling firm: Edge Pharma, Colchester, VT
Classification: Class II
Status: Terminated
Recall initiated: 6 Dec 2021
FDA classified: 24 Jan 2022
Reported: 2 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Pain Medication

Timeline

6 Dec 2021	Recall initiated by company
24 Jan 2022	Classified by FDA	+49 days
2 Feb 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03

Where it was distributed

nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

11-2021-02@2 12/16/2021

Where was it sold?

nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

55 other products · FDA event 89172

This product is part of a recall event; the main page for the event is Edetate Disodium (EDTA), Sterile Ophthalmic Solution recalled.

Reported	Class	Recall	Company	Reason	Where
2 Feb 2022	CLASS II	Edetate Disodium (EDTA), Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Edetate Disodium (EDTA), Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Mvasi, (bevacizumab-awwb), Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Phenol, Topical Solution (PF) Multiple Dose Vial recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Profound-PE Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Gemcitabine, Sterile Intravesical Solution recalled by Edge Pharma	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Dibutyl Squaric Acid, Topical Solution (PF) recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Dexamethasone sodium phosphate, sterile otic solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Phenylephrine HCl, 1mg/ (0.1mg/mL) per syringe recalled by Edge Pharma	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine recalled	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Promethazine HCl Topical Ointment recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Vitamin K (Vitamin K ) Oral Solution (PF) recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Betadine (povidone-iodine), Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming recalled	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Lidocaine HCl/Epinephrine, Sterile Buffered Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine recalled	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Mitomycin-C Sterile Ophthalmic Solution, Preservative Free recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Dibutyl Squaric Acid, Topical Solution recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Moxifloxacin, Sterile Ophthalmic Solution for Injection recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Lidocaine HCl / Oxymetazoline HCl Nasal Solution recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Vancomycin HCl Oral Solution (PF) 125mg recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl recalled	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Vancomycin HCl in 0.9% Sodium Chloride Injection recalled by Edge Pharma	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Profound Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Profound Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Dexamethasone sodium phosphate recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Lidocaine HCl Sterile Buffered Solution for Injection recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Neostigmine methylsulfate, 5 mg/ (1 mg/mL) per syringe recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Cefuroxime, Sterile Ophthalmic Solution for Injection recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Csf-hc Otic Insufflation Capsule, Sulfacetamide recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Phenol, Sterile Solution for Injection (PF), 6% per vial recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Mitomycin-C, 40mg/ (1mg/mL) per syringe recalled by Edge Pharma	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Phenylephrine HCl 0.5 mg/, (0.1 mg/mL) per syringe recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Cantharidin Gel-Forming Suspension, 0.7% per vial recalled	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Methacholine Challenge 5-Syringe Test Kit recalled by Edge Pharma	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Vancomycin HCl, Sterile Ophthalmic Solution for Injection recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase/mL) recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Trypan Blue 0.03% per syringe recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm recalled	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1% recalled	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Vancomycin HCl in 0.9 % Sodium Chloride Injection recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Ceftazidime, Sterile Ophthalmic Solution for Injection recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	CSF Otic Insufflation Capsule recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Methotrexate, USP, Sterile Solution for Injection (PF) recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022	CLASS II	Tetracaine HCl Nasal Solution recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022	CLASS II	Phenylephrine HCl, Sterile Solution for Injection, (PF) recalled	Edge Pharma	Sterility	Nationwide

More recalls from Edge Pharma

All 62

Reported	Class	Recall	Company	Reason	Where
2 Feb 2022Drug	CLASS II	Phenylephrine HCl, Sterile Solution for Injection, (PF) recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022Drug	CLASS II	Tetracaine HCl Nasal Solution recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022Drug	CLASS II	Methotrexate, USP, Sterile Solution for Injection (PF) recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022Drug	CLASS II	CSF Otic Insufflation Capsule recalled by Edge Pharma	Edge Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Feb 2022Drug	CLASS II	Ceftazidime, Sterile Ophthalmic Solution for Injection recalled	Edge Pharma	Sterility	Nationwide

Other Phenylephrine recalls

All 122

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Phenylephrine Hydrochloride Injectable Solution, 40mg recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
30 Apr 2025Drug	CLASS II	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled	Denver Solutions	Sterility	Nationwide
26 Feb 2025Drug	CLASS I	Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled	Provepharm	Particulate Matter	Nationwide
8 Jan 2025Drug	CLASS II	phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled	Hikma Injectables USA	Sterility	Nationwide
29 May 2024Drug	CLASS I	Phenylephrine in 0.9% Sodium Chloride Injection recalled	Hikma Injectables USA	Labeling Errors	5 states