The Recall Desk

State

Montana product recalls

73,495 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.

These figures cover only the 3,572 recalls whose distribution notice names Montana specifically. The 73,495 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

23876–23900 of 77067

  • HighFDA (Drugs)·D-0050-2022·2021-11-03

    Testosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns

    First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.

    Product
    TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighCPSC·22016·2021-11-03

    Usines Giant Factories Gas Water Heaters Recalled for Carbon Monoxide Risk

    Usines Giant Factories is recalling about 168 gas water heaters with Emerson control valves that can short circuit, overheat, and release carbon monoxide. The company will replace the control valve free of charge.

    Product
    Usines Giant Factories Gas Water Heaters with Emerson control valves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2022·2021-11-03

    Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date

    W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.

    Product
    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Drugs)·D-0056-2022·2021-11-03

    Calcium Gluconate 10% Injectable Recalled for Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.

    Product
    CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0177-2022·2021-11-03

    Bivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier

    Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.

    Product
    Bivona Aire-Cuf Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2022·2021-11-03

    Bivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier

    Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.

    Product
    Bivona Uncuffed Wire Endotracheal Tubes,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.

    Product
    REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0175-2022·2021-11-03

    Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results

    AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.

    Product
    Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0079-2022·2021-11-03

    Rizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities

    Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0172-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateCPSC·22015·2021-11-03

    Elektron BP-1 Power Handles Recalled for Fire and Burn Hazards

    Elektron Power Handle BP-1 units can short circuit and overheat, creating fire and burn risks. Consumers should stop using them immediately and contact Elektron for a full refund.

    Product
    Elektron BP-1 Power Handles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0091-2022·2021-11-03

    Gatifloxacin Ophthalmic Solution Recalled for Failed Stability Tests

    Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to failed water loss tests that may affect drug concentration. The recall affects 16,272 bottles distributed nationwide.

    Product
    Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2022·2021-11-03

    Cyclosporin 0.2% Oil Ophthalmic Suspension Recall Due to Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.

    Product
    CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0067-2022·2021-11-03

    Sodium Selenite Injectable Solution Recalled for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling Sodium Selenite 200mcg/ml injectable solution due to FDA inspection findings regarding lack of assurance of sterility. Approximately 494 patients in seven states received prescriptions for this product.

    Product
    SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0077-2022·2021-11-03

    Afassco Pain Free Plus X-Strength Tablets Recalled for Failed Stability

    Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.

    Product
    Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0064-2022·2021-11-03

    MIC/B12A/B6 Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling MIC/B12A/B6 injectable medication because FDA inspection identified concerns about sterility assurance. The recall affects 494 patients across seven states.

    Product
    MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0078-2022·2021-11-03

    Rizatriptan Benzoate Tablets Recall Due to Out-of-Specification Impurities

    MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.

    Product
    RIZATRIPTAN — RIZATRIPTAN (RIZATRIPTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2022·2021-11-03

    Magnesium Chloride Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.

    Product
    Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0076-2022·2021-11-03

    Xpect First Aid Extra Strength Pain Away tablets recalled for failed stability specifications

    Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away tablets nationwide due to out-of-specification results for Salicylic Acid, a compound related to Aspirin, indicating failed stability testing.

    Product
    Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0075-2022·2021-11-03

    Advance Formula Pain Reliever tablets recalled for failed stability specifications

    Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for Salicylic Acid, an Aspirin-related compound.

    Product
    Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0074-2022·2021-11-03

    North by Honeywell Pain Stopper Extra Strength tablets recalled for failed stability

    Ultra Seal Corporation is recalling North by Honeywell Pain Stopper Extra Strength tablets nationwide because stability testing found out-of-specification results for Salicylic Acid, an aspirin-related compound.

    Product
    North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Labeled with Incorrect Expiration Date

    W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.

    Product
    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Drugs)·D-0060-2022·2021-11-03

    Methylcobalamin injection recalled due to sterility assurance concerns

    Red Mountain Compounding Pharmacy is recalling a methylcobalamin injectable solution after FDA inspection raised concerns about the lack of assurance of sterility.

    Product
    METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0073-2022·2021-11-03

    AERO Tab Pain Reliever Tablets Recalled for Failed Stability Specifications

    Ultra Seal Corporation is recalling AERO Tab Pain Reliever tablets nationwide because out-of-specification results were found for Salicylic Acid, an Aspirin-related compound, indicating failed stability testing.

    Product
    AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0068-2022·2021-11-03

    Loratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits

    Sun Pharmaceutical Industries is recalling 22,752 blister packs of Loratadine-D Extended-Release Tablets (10mg/240mg) distributed nationwide due to failed moisture limits. The affected lot is AC14635 with expiration date 12/2022.

    Product
    LORATADINE AND PSEUDOEPHEDRINE SULFATE — LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide