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.

1276–1300 of 3531

  • ModerateFDA (Devices)·Z-2543-2023·2023-09-20

    Landauer nanoDot radiation dosimeters recalled for potential accuracy deviation

    Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.

    Product
    nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-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 (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-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 (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 (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-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 (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-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 (Devices)·Z-2457-2023·2023-08-30

    Medicrea Recalls IMPIX TLIF Fusion Devices for Packaging Defects

    Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.

    Product
    IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1096-2023·2023-08-30

    Blis-To-Sol Tolnaftate Liquid Recalled for Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Blis-To-Sol Liquid (Tolnaftate) nationwide due to manufacturing practice violations. No illnesses have been reported.

    Product
    Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1089-2023·2023-08-30

    Drug manufacturer recalls Protex hand sanitizer due to manufacturing quality deviations

    Parker Laboratories is recalling Protex Foaming Hand Sanitizer due to manufacturing quality control deviations. The voluntary recall affects products distributed nationwide and internationally.

    Product
    Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2023·2023-08-30

    Cervical intervertebral fusion devices recalled for packaging defect

    Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.

    Product
    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1091-2023·2023-08-30

    Helix Tri-Active Therapy Cream Recalled for Manufacturing Quality Deviations

    Parker Laboratories is voluntarily recalling Helix Tri-Active Therapy Cream due to manufacturing quality control deviations. The recall affects products with lot numbers A1221010 and A1221011, expiring December 9, 2023, distributed in the United States, Singapore, Korea, and Hong Kong.

    Product
    Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2023·2023-08-30

    Medicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect

    Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.

    Product
    IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
    Category
    Medical Device
    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
  • ModerateFDA (Drugs)·D-1094-2023·2023-08-30

    Moxifloxacin-Bromfenac Eye Drops Recalled for Subpotent Bromfenac Levels

    Imprimis NJOF, LLC is recalling 2,683 bottles of Moxifloxacin-Bromfenac eye drops nationwide because Bromfenac levels fall below the 90-110% specification (affected lots: 22DEC047 exp. 9/16/23, 23FEB057 exp. 11/24/23).

    Product
    Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1092-2023·2023-08-30

    Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations

    Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.

    Product
    Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
    Category
    Drug
    Distribution
    Distributed nationwide