The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

3301–3325 of 21589

  • ModerateFDA (Food)·F-1500-2023·2023-09-20

    La Reyna Queso Dip recalled for temperature control violations

    Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Queso Dip due to temperature control violations during shipment. The product was not quarantined after being received out of specification.

    Product
    La Reyna Queso Dip. Product Code 1781. Net Wt 16 oz. UPC 7 52830-92650 9. Keep Refrigerated. Ingredients: American White Cheese, 2% Milk, White Vinegar, Onion, Salt, Jalapeno Peppers. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2535-2023·2023-09-20

    Procedural Kits with Ultrasonic Gel Recalled for Inappropriate Use Labeling

    Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1498-2023·2023-09-20

    La Reyna Gluten Free Guacamole Recalled for Temperature Control Failure

    Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Gluten Free Guacamole distributed to IA, MI, MN, and WI because the product was shipped at improper temperatures without quarantine.

    Product
    La Reyna Guacamole, Gluten Free. Product Code 1780. Net Wt 16 oz. UPC 7 52830-92610 3. Ingredients: Avocado, Tomato, Cilantro, Salt, Onions. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1499-2023·2023-09-20

    La Reyna Salsa Roja recalled for improper temperature storage during distribution

    Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Salsa Roja due to temperature storage violations. The product was shipped to customers without proper quarantine after being stored outside required refrigeration specifications.

    Product
    La Reyna Salsa Roja, Gluten Free / Medium. Product Code 1783. Net Wt 16 oz. UPC 7 52830-92630 1. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2562-2023·2023-09-20

    Landauer nanoDot Radiation Dosimeter Recall for Accuracy Defect

    Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.

    Product
    nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2532-2023·2023-09-20

    ASG-001 ultrasound gel recalled for mislabeling regarding use instructions

    Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.

    Product
    ASG-001; Ultrasound gel
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2580-2023·2023-09-20

    Denture relining kit recalled for outer box labeling error

    Keystone Industries is recalling 240 units of Henry Schein Hard Line Chairside Reline kits because the outer box is labeled as Soft Line, though the contents and instructions are correctly labeled.

    Product
    Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2579-2023·2023-09-20

    Copaliner Cavity Varnish Recalled for Solvent Mislabeling Error

    Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.

    Product
    Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2536-2023·2023-09-20

    Ultrasound Gel Procedural Kits Recalled for Inappropriate Use Mislabeling

    Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to the US, Canada, UK, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2581-2023·2023-09-20

    Welch Allyn Connex Spot Monitor Recalled for Improper Copper Tape Placement

    Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.

    Product
    Welch Allyn Connex Spot Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1143-2023·2023-09-13

    Prescription Drug Recall: Nexlizet Tablets Failed Dissolution Specifications

    Esperion is recalling Nexlizet (bempedoic acid and ezetimibe) tablets nationwide due to failed dissolution specifications identified during stability testing. Approximately 45,240 bottles are affected.

    Product
    NEXLIZET — NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2521-2023·2023-09-13

    ZVU Functional GI Software Recall for Incorrect Software Revision Labeling

    ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.

    Product
    ZVU Functional GI Software, REF: ZVU-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1493-2023·2023-09-13

    Parent's Choice and Tippy Toes Sensitivity Infant Formula Recalled

    PBM Nutritionals recalls Parent's Choice and Tippy Toes Sensitivity Premium Infant Formula due to inadvertent market release of product that had been rejected. Affected batches were distributed across multiple states.

    Product
    Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cans
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-1146-2023·2023-09-13

    Prescription Dental Toothpaste Recalled Due to Incorrect Carton Labeling

    AvKARE is recalling Sodium Fluoride 1.1% prescription dental toothpaste because cartons are labeled as Capsaicin Cream 0.025%, though the tubes are correctly labeled. Approximately 35,184 tubes have been distributed to 19 consignees.

    Product
    SODIUM FLOURIDE — SODIUM FLOURIDE (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1145-2023·2023-09-13

    Fosfomycin Tromethamine Antibiotic Recalled for Failed Stability Specifications

    Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.

    Product
    FOSFOMYCIN TROMETHAMINE — FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1492-2023·2023-09-13

    Ruby Mountain Spring Water Recalled for Coliform Contamination

    Ruby Mountain Spring Water 3 and 5 gallon jugs are recalled due to positive coliform findings. Consumers should not drink the water.

    Product
    Ruby Mountain Spring Water 3 and 5 gallon plastic water jugs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1142-2023·2023-09-06

    Sabril (vigabatrin) oral solution recalled for cross-contamination

    Lundbeck LLC recalls Sabril (vigabatrin) oral solution nationwide due to potential cross-contamination. The recall affects 10,543 cartons.

    Product
    SABRIL — SABRIL (VIGABATRIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1486-2023·2023-09-06

    Grape Juice Recalled for Bloating in Sealed Cups

    Lyons Magnus LLC is recalling GFS Harvest Valley Grape Juice in 4 fl oz cups due to signs of bloating in containers. Consumers in multiple states should not consume and should dispose of the product safely.

    Product
    GFS Harvest Valley Grape Juice packaged in 4 fl oz opaque white plastic cup 96 cups per case
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1269-2023·2023-09-06

    Siemens Atellica CH Total Protein II Recalled for Reagent Carryover

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.

    Product
    Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1466-2023·2023-09-06

    Gourmet Garden Herbs Recalled for Improper Temperature Storage

    C & S Wholesale Grocers is recalling 29,469 cases of Gourmet Garden herb and spice products sold at Stop & Shop stores in the New York Metro region due to improper temperature storage. Consumers should discard these products.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Gourmet Garden Jalapeno Groumet Garden Roasted Garlic Gourmet Garden Italian Herb Gourmet Garden Parsley Blend Gourmet Garden Cilantro Gourmet Garden Ginger Gourmet Garden Chunky Garlic Gourmet
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1103-2023·2023-08-30

    Prescription Injection Recalled Due to Missing or Peeled Labels

    Baxter Healthcare Corporation recalls Bendamustine Hydrochloride injection nationwide because labels are missing or partially peeled off vials, raising the risk of medication errors.

    Product
    BENDAMUSTINE HYDROCHLORIDE — BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1095-2023·2023-08-30

    Prescription Drug Trandolapril and Verapamil Tablets Recalled for Subpotency

    Glenmark Pharmaceuticals is recalling Trandolapril and Verapamil Extended-Release Tablets because they are subpotent—they do not contain their full specified amount of active ingredient. The issue was found during three-month stability testing.

    Product
    TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1093-2023·2023-08-30

    FDA Recalls Helix CBD Clinical Cream for Manufacturing Process Violations

    Parker Laboratories is recalling Helix CBD Clinical Cream due to manufacturing process deviations. The FDA Class II recall affects batches distributed nationwide and internationally; consumers should discontinue use and contact the manufacturer.

    Product
    Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide