Year
2021 Product Recalls
4,229 product recalls issued in 2021 across CPSC, FDA, and USDA datasets.
4,229 recalls
CriticalFDA
Valisa Mfg Llc
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735,...
Drugs7,704 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edg...
Topical Drugs80 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge ...
Topical Drugs0 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, ...
Injectable Drugs199 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
Topical Drugs1,861 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose C...
Oral Drugs175 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesica...
Drugs627 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05...
Topical Drugs63 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single...
Injectable Drugs323 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colche...
Injectable Drugs6,535 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edg...
Topical Drugs26,917 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 ...
Topical Drugs7,788 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr....
Oral Drugs757 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthal...
Topical Drugs1,773 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LL...
Topical Drugs2,204 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules ...
Injectable Drugs8,140 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 8...
Topical Drugs1,173 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe...
Injectable Drugs2,750 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical ...
Topical Drugs163 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 054...
Topical Drugs20 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe...
Injectable Drugs860 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma,...
Inhaled / Nasal Drugs386 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, ...
Oral Drugs6,925 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Mul...
Topical Drugs40 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multi...
Oral Drugs418 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-fil...
Injectable Drugs749 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Her...
Injectable Drugs30 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Conta...
Oral Drugs353 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-f...
Injectable Drugs1,825 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syri...
Injectable Drugs2,568 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topic...
Oral Drugs221 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colc...
Topical Drugs56 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Us...
Topical Drugs2,463 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edg...
Injectable Drugs4,465 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercule...
Injectable Drugs160 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular...
Injectable Drugs1,720 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 ...
Oral Drugs440 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topica...
Topical Drugs154 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic U...
Topical Drugs363 affectedDec 6, 2021
High RiskFDA
Medique Products
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count...
Oral Drugs3,260,400 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules ...
Injectable Drugs309 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colches...
Drugs860 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single U...
Topical Drugs2,562 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colc...
Injectable Drugs3,747 affectedDec 6, 2021
High RiskFDA
Organics Corporation Of America Dba Ambix Laboratories
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadho...
Topical Drugs4,214 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colches...
Topical Drugs1,173 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit in...
Drugs1,007 affectedDec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per s...
Injectable Drugs3,360 affectedDec 6, 2021