State

Montana product recalls

73,478 recalls have nationwide distribution and so reach Montana. 3,572 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total: 3,572
Critical: 689
Severe: 952
Most recent: 2026-10-14

Of the 3,572 recalls naming Montana we have scored against our rubric, 689 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 952 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,572 recalls whose distribution notice names Montana specifically. The 73,478 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

22901–22925 of 77050

SevereFDA (Drugs)·D-0398-2022·2022-02-02
Cefuroxime Sterile Ophthalmic Injection Recalled Due to Sterility Concerns
Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.
Product
Cefuroxime, 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0399-2022·2022-02-02
Dexamethasone Sodium Phosphate Otic Injection Syringes Recalled for Lack of Sterility Assurance
Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.
Product
Dexamethasone 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0418-2022·2022-02-02
Phenylephrine Injection Recall Due to Sterility Assurance Concerns
Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0394-2022·2022-02-02
ALUM Concentrate IV Bags Recalled for Lack of Sterility Assurance
Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.
Product
ALUM 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0395-2022·2022-02-02
Lidocaine HCl Sterile Buffered Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.
Product
Lidocaine 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0410-2022·2022-02-02
Moxifloxacin Ophthalmic Injection Syringes Recalled for Sterility Risk
Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0450-2022·2022-02-02
Pioglitazone Tablets Recalled for Superpotent and Failed Specifications
Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.
Product
PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0415-2022·2022-02-02
Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0424-2022·2022-02-02
Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0422-2022·2022-02-02
Ophthalmic Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0494-2022·2022-02-02
Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material
Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.
Product
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric…
Category
Medical Device
Distribution
17 states
SevereNHTSA·22V049000·2022-02-02
Blue Bird Recalls 2023 Vision School Buses Due to Brake Software Defect
Blue Bird is recalling 2023 Vision school buses because software may fail to engage brakes during wheelchair lift operation, increasing injury risk.
Product
BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0401-2022·2022-02-02
Edge Pharma Edetate Disodium Ophthalmic Solution Recall for Sterility Concerns
Edge Pharma is recalling Edetate Disodium (EDTA) 3% Sterile Ophthalmic Solution due to lack of assurance of sterility. The product is a single-dose eye drop used for topical ophthalmic use.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0402-2022·2022-02-02
Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance
Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·22V051000·2022-02-02
Kia Recalls Sportage and K900 Models for Fire Risk
Kia is recalling 2014-2018 Sportage and K900 vehicles because a faulty module could cause an engine compartment fire.
Product
KIA — KIA SPORTAGE, K900
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0412-2022·2022-02-02
MVASI Sterile Ophthalmic Solution Lacks Assured Sterility
Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0414-2022·2022-02-02
Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma
Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0425-2022·2022-02-02
Vancomycin HCl Injection Recall for Lack of Sterility Assurance
Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0426-2022·2022-02-02
Vancomycin HCl Injection Recalled for Sterility Assurance Issues
Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0396-2022·2022-02-02
Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance
Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.
Product
Lidocaine 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0419-2022·2022-02-02
Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall
Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0408-2022·2022-02-02
Mitomycin-C Sterile Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0413-2022·2022-02-02
Phenol Injection Solution Recall Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.
Product
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.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0493-2022·2022-02-02
Trilogy Evo Ventilator Recalled for Foam Degradation Risk
Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.
Product
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through…
Category
Medical Device
Distribution
17 states
SevereFDA (Drugs)·D-0411-2022·2022-02-02
Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.
Product
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
Category
Drug
Distribution
Distributed nationwide