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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 4,441–4,460 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01

by Edge Pharma, LLC

Reason
CGMP Deviations
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

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-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

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

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.