The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

40151–40175 of 50506

  • HighFDA (Drugs)·D-0156-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST2 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST2 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.

    Product
    Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2015·2014-11-05

    Roche Recalls ACCU-CHEK Spirit Combo Insulin Pumps Due to Time Settings

    Roche is recalling 8,116 ACCU-CHEK Spirit Combo insulin pumps because a faulty capacitor may cause time and date settings to reset, potentially shifting insulin delivery schedules.

    Product
    ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0171-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Fentanyl/Bupivacaine Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling fentanyl/bupivacaine injectable syringes due to quality control observations that present a risk to sterility assurance.

    Product
    Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0126-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2015·2014-11-05

    Siemens Phenytoin Reagent Cartridge Recalled for Potential Test Bias

    Siemens Healthcare Diagnostics is recalling 1,733 Phenytoin Flex Reagent Cartridges due to internal testing that confirmed a low absorbance range, which may result in biased or imprecise test results.

    Product
    siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0092-2015·2014-11-05

    United Natural Trading Recalls Organic Campfire Trail Mix for Undeclared Cashews

    United Natural Trading is recalling three brands of Organic Campfire Trail Mix because they may contain undeclared cashew kernels.

    Product
    1) Nature's Place Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by DZA Brands LLC 2110 Executive Drive Salisbury, NC 28147; UPC 725439951920 2) Nature's Promise Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by Foodhold USA LLC Landover…
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0065-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including calcium chloride, due to quality control observations that risk sterility assurance.

    Product
    Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0149-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control issues may compromise sterility assurance.

    Product
    Tri-mix, 30 mg/1 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 1 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Methylcobalamin 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 150 mg/mL injections due to quality control issues that may compromise sterility assurance.

    Product
    Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations of Sodium tetradecyl sulfate due to quality control issues affecting sterility assurance.

    Product
    Sodium tetradecyl SO4 stock solution 6% solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0118-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including phentolamine mesylate, due to quality control issues affecting sterility assurance.

    Product
    Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2015·2014-11-05

    CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure

    CP Medical is recalling five lots of Monoswift PGCL absorbable surgical sutures because they failed to meet minimum tensile strength requirements over their shelf life.

    Product
    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0020-2015·2014-11-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications S.A. is recalling eight Proteus 235 Proton Therapy Systems due to a rare risk of exceeding prescribed radiation doses.

    Product
    Proteus 235 Proton Therapy System for cancer treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0070-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including chorionic gonadotropin/mannitol, due to quality control issues affecting sterility assurance.

    Product
    Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0415-2015·2014-11-05

    Good Herbs Skullcap Recalled for GMP Violations

    Good Herbs, Inc. is recalling Skullcap herb bottles because they were not manufactured under Good Manufacturing Practices (GMPs).

    Product
    Good Herbs, Inc., SKULLCAP, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works
    Category
    Food
    Distribution
    18 states
  • HighNHTSA·14V709000·2014-11-05

    Ford Recalls 2014 F-150 Trucks Due to Brake Light Switch Defect

    Ford is recalling certain 2014 F-150 vehicles because an improperly adjusted brake pedal position switch may cause brake lights to illuminate with a delay or not at all.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Hyaluronidase Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling hyaluronidase injection solution due to quality control issues that may compromise sterility.

    Product
    Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0099-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 1 mg/mL injectable vials due to quality control issues that may compromise sterility assurance.

    Product
    Methylcobalamin (PF) 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0167-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix T50 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T50 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0155-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST1 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST1 injectable vials because FDA inspection findings raised concerns about sterility assurance.

    Product
    Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tetracycline Powder Kits for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tetracycline 250 mg powder kits due to quality control observations that present a risk to sterility assurance.

    Product
    Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix 2, due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Hydromorphone HCl Injectable Syringes

    Martin Avenue Pharmacy is voluntarily recalling compounded Hydromorphone HCl injectable syringes due to quality control observations that present a risk to sterility assurance.

    Product
    Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0158-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST9-A Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST9-A injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix ST9-A, 30 mg/2 mg/80 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide