Category
Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPhenylephrine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPhenylephrine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPHENYLephrine, 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPhenylephrine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPhenylephrine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPhenylephrine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPhenylephrine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIPhenol, 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.
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIMVASI, (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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IINeostigmine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIMoxifloxacin, 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIMitomycin-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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIMitomycin-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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIMitomycin-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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIMethotrexate, 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIMethacholine 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 Pharm
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IILidocaine 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIGemcitabine, 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIEpinephrine/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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIEdetate 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
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIEdetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
Lack of Assurance of Sterility.
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIDexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IICefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IICeftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IILidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IILidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugEdge Pharma, LLCClass IIALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
Lack of Assurance of Sterility
- 2022-02-02FDA-DrugAscend Laboratories, LLCClass IIMetoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
Failed Dissolution Specifications.
- 2022-02-02FDA-DrugVIONA PHARMACEUTICALS INCClass IIMetformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- 2022-01-26FDA-DrugMylan Pharmaceuticals IncClass ISemglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday BriefExplore other recall topics
By hazard
By state