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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 4,461–4,480 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01

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/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01

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, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01

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, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01

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, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10

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 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05

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 / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01

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

Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.

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

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, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13

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

Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05

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

Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01

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

Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01

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

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 Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01

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

Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01

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

Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05

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

Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01; Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01; Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01; and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446

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

Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18

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

Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50

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

Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

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

Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10

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.