State

Montana product recalls

73,219 recalls have nationwide distribution and so reach Montana. 3,571 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total: 3,571
Critical: 689
Severe: 785
Most recent: 2026-09-23

Of the 3,571 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 785 (22%) are Severe.

Which agencies issued them

These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,219 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

17476–17500 of 76790

HighFDA (Drugs)·D-0445-2023·2023-03-15
FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations
Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.
Product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1233-2023·2023-03-15
Monaco RTP System software may calculate radiation therapy doses inaccurately
Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2023·2023-03-15
Baxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection
Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.
Product
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2023·2023-03-15
CardioMEMS PA Sensor models affected by radio-frequency range at high elevations
St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1225-2023·2023-03-15
CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations
St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2023·2023-03-15
Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure
Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.
Product
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0436-2023·2023-03-15
Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification
Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.
Product
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0419-2023·2023-03-15
Daily Harvest French Lentil Crumbles Recalled for Gastrointestinal Illness
Daily Harvest French Lentil + leek Crumbles (Item L02-VEGBN) are being recalled due to complaints of gastrointestinal illness. The recall affects 28,776 units distributed nationwide with lot codes from September through November 2022.
Product
Daily Harvest French Lentil + leek Crumbles, Item ID L02-VEGBN, Net Wt. 12 oz. (340g) Keep Frozen, Cook Thoroughly. Perishable. Store Frozen. Cook Thoroughly to internal temperature of 165F. Distr. by Daily Harvest Inc. New York, NY 10013.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0434-2023·2023-03-15
Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency
B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.
Product
HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0444-2023·2023-03-15
FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations
Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.
Product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1228-2023·2023-03-15
Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk
Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.
Product
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1231-2023·2023-03-15
Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy
Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2023·2023-03-15
Cardiosave Rescue IABP Helium Regulator Failures May Impair Function
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1223-2023·2023-03-15
CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations
Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0443-2023·2023-03-15
FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations
Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.
Product
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0450-2023·2023-03-15
FDA Recalls Nose Better Gel Due to Manufacturing Process Deviations
Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.
Product
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0435-2023·2023-03-15
Heparin Sodium Injection Recalled Due to Labeling Issue
Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.
Product
HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0451-2023·2023-03-15
Sodium fluoride oral rinse recalled for manufacturing deviations
Activator Concentrate, a sodium fluoride oral rinse manufactured by Ecometics, Inc., was voluntarily recalled due to manufacturing practice deviations. The recall affected 34,320 bottles distributed nationwide.
Product
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0454-2023·2023-03-15
OTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date
Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.
Product
DIBUCAINE — DIBUCAINE (DIBUCAINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0457-2023·2023-03-15
Drug Recall: Purely Soothing MSM Nasal Spray due to manufacturing deviations
Pharmedica USA is recalling Purely Soothing MSM Nasal Spray (15%, Lot #1808051) due to manufacturing practice violations. The recall affects 995 bottles distributed nationwide and internationally.
Product
Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2023·2023-03-15
Medicated Balm Recalled for Manufacturing Process Deviations
Ecometics, Inc. is voluntarily recalling Vencedor medicated balm (capsaicin 0.028%) nationwide due to manufacturing process deviations. The recall affects Lot #2E021A with expiration date January 2025.
Product
Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0449-2023·2023-03-15
Drug manufacturer recalls Soltice Quick-RUB nationwide due to manufacturing deviations
Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.
Product
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2023·2023-03-15
BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard
The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.
Product
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1226-2023·2023-03-15
Dental anaerobic glue recalled for incorrect expiration date labeling
Preat Corp is recalling 652 units of PREAT NOBIL GRIP dental adhesive due to incorrect expiration dates on product labels. Consumers should verify lot numbers and contact the manufacturer.
Product
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0437-2023·2023-03-15
FDA Recalls NaturalCare bioAllers Nasal Spray Due to Manufacturing Defects
Nutraceutical Corporation recalls NaturalCare bioAllers Allergy Nasal Spray nationwide due to manufacturing quality deviations in raw materials. The recalled lots show discoloration and do not meet FDA Good Manufacturing Practice standards.
Product
NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
Category
Drug
Distribution
Distributed nationwide