The Recall Desk

State

Montana product recalls

72,969 recalls have nationwide distribution and so reach Montana. 3,568 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,568
Critical
689
Severe
783
Most recent
2026-09-16

Of the 3,568 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 783 (22%) are Severe.

These figures cover only the 3,568 recalls whose distribution notice names Montana specifically. The 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5701–5725 of 76537

  • HighFDA (Food)·H-0470-2025·2025-08-20

    Helados Mexico choco dipped paletas list cream without declaring milk

    Helados Mexico Choco Dipped Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 70,044 units affected.

    Product
    Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2025·2025-08-20

    Polyaxial screws in lot 8-4528 recalled over possible incorrect labeling

    PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 65 40-S, lot 8-4528, are recalled because the screws may be incorrectly labeled. 16 units are affected.

    Product
    Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2025·2025-08-20

    Custom waste management kit tubing may trap air in the line

    Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.

    Product
    Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0581-2025·2025-08-20

    Metoprolol tartrate tablets recalled for nitrosamine above acceptable daily intake level

    Metoprolol Tartrate Tablets USP, 50 mg, distributed by Westminster Pharmaceuticals, are recalled nationwide after N-nitroso-metoprolol was found above the established Acceptable Daily Intake. 16,672 bottles are affected.

    Product
    Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0588-2025·2025-08-20

    Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit

    Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side

    Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0464-2025·2025-08-20

    Strawberry con crema paleta 6-packs recalled for cream without milk declaration

    La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.

    Product
    La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2025·2025-08-20

    FARAWAVE ablation catheters may have cracks in the distal electrode bands

    FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.

    Product
    FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0499-2025·2025-08-20

    Clover Valley instant coffee may contain glass pieces in jars

    Clover Valley Instant Coffee in 8 oz glass jars is being recalled because of the potential presence of glass pieces. 84,240 units are affected.

    Product
    Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072
    Category
    Food
    Distribution
    48 states
  • HighFDA (Drugs)·D-0586-2025·2025-08-20

    Sodium chloride injection containers recalled over potential fluid leakage at weld site

    B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0460-2025·2025-08-20

    Mango con crema paletas recalled for listing cream without milk allergen declaration

    La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.

    Product
    La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2025·2025-08-20

    Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level

    Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.

    Product
    Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0469-2025·2025-08-20

    Helados Mexico variety paletas list cream without declaring milk as source

    Helados Mexico Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 42,488 units are affected.

    Product
    Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0465-2025·2025-08-20

    La Michoacana variety paletas list cream without declaring milk as source

    La Michoacana Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 29,180 units are affected.

    Product
    La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0576-2025·2025-08-20

    Amlodipine and olmesartan tablets recalled after failing dissolution specification testing

    Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2025·2025-08-20

    Thyroglobulin assay reagent recalled after lot generated erroneously high patient results

    Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.

    Product
    Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2025·2025-08-20

    Glenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level

    Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0468-2025·2025-08-20

    Mini variety paletas recalled because label lists cream without declaring milk

    Helados Mexico Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 643,519 units are affected.

    Product
    Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0459-2025·2025-08-20

    La Michoacana strawberry paletas list cream without declaring milk as source

    La Michoacana Strawberry Con Crema Single Serve Paletas are being recalled because the label includes the ingredient cream but does not include milk as the source. 62,864 units affected.

    Product
    La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2025·2025-08-20

    Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit

    Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2025·2025-08-20

    High pressure tubing may separate and trap air in the line

    High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.

    Product
    High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0466-2025·2025-08-20

    Variety paleta 16-count packs recalled over cream ingredient missing milk source

    La Michoacana Variety Paletas, 16-count 44 oz packs, are recalled nationwide because the label lists cream but does not declare milk as its source. 2,241 units are affected.

    Product
    La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0463-2025·2025-08-20

    Coconut con crema 6-pack paletas recalled over undeclared milk in cream

    La Michoacana Coconut Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 47,065 units are affected.

    Product
    La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0458-2025·2025-08-20

    Single serve coconut con crema paletas recalled for missing milk source declaration

    La Michoacana Coconut Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 74,654 units are affected.

    Product
    La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2025·2025-08-20

    Custom tubing kits recalled because high pressure tubing may trap air

    Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.

    Product
    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
    Category
    Medical Device
    Distribution
    Distributed nationwide