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.

1076–1100 of 3531

  • ModerateFDA (Drugs)·D-0186-2024·2024-01-03

    Leader Nasal Decongestant PE recalled due to improper storage conditions

    Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg, 18-tablet cartons) nationwide because products were exposed to temperatures outside the labeled storage conditions. Batch P125514 is affected.

    Product
    Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2024·2024-01-03

    Medivators Advantage Endoscope Hookup Accessories Recalled for Illegible Identification Labels

    Steris Corporation recalls Medivators Advantage endoscope hookup accessories because identification labels become illegible as ink degrades, potentially preventing proper hookup identification and delaying patient procedures.

    Product
    Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 AS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2024·2024-01-03

    Colgate Total SF Toothpaste recalled for improper storage temperature exposure

    Colgate Total SF Toothpaste (Batch 1293US561C, 4.8 oz, Clean Mint) distributed nationwide is being recalled due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions.

    Product
    Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0182-2024·2024-01-03

    Fluticasone Propionate Nasal Spray Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling Fluticasone Propionate Nasal Spray (50MCG per spray) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Nationwide distribution affected.

    Product
    FLUTICASONE PROPIONATE — FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2024·2024-01-03

    Prescription thyroid drug recalled due to temperature storage deviation

    ARMOUR THYROID 120 mg tablets in batch W05543 are being recalled nationwide due to exposure to temperatures outside the labeled storage conditions. No illnesses or injuries have been reported.

    Product
    ARMOUR THYROID — ARMOUR THYROID (THYROID, PORCINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0194-2024·2024-01-03

    Propranolol Hydrochloride 20 mg Tablets Recalled for Temperature Storage Deviations

    Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.

    Product
    PROPRANOLOL HYDROCHLORIDE — PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0178-2024·2024-01-03

    Doxycycline Capsules Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare is recalling Doxycycline 100 mg Capsules nationwide due to exposure to temperatures outside labeled storage conditions. No illnesses have been reported.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0173-2024·2024-01-03

    Citalopram Tablets Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling Citalopram 20mg tablets (batch 3131748) nationwide due to exposure to temperatures outside labeled storage conditions during manufacturing.

    Product
    CITALOPRAM — CITALOPRAM (CITALOPRAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2024·2024-01-03

    Liberty Select Cycler Displays Incorrect Timestamp on Treatment Reports

    Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.

    Product
    Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0185-2024·2024-01-03

    FDA Recalls Jardiance Diabetes Tablets Due to Storage Temperature Deviations

    Jardiance 25 mg tablets distributed nationwide were recalled due to CGMP deviations where products were exposed to temperatures outside the labeled storage conditions. The recall affects batch D41919.

    Product
    JARDIANCE — JARDIANCE (EMPAGLIFLOZIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0195-2024·2024-01-03

    OTC Throat Lozenges Recalled for Temperature Storage Deviation

    Ricola Cherry Honey Herb Throat Drops are recalled because products in batch 2000058693 were exposed to temperatures outside the labeled storage conditions during distribution. The Class II recall affects nationwide shipments.

    Product
    NATURAL CHERRY HONEY HERB THROAT DROPS — NATURAL CHERRY HONEY HERB THROAT DROPS (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0165-2024·2024-01-03

    Amoxicillin oral suspension recalled for temperature storage deviation

    CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension nationwide due to CGMP deviations. Products were exposed to temperatures outside their labeled storage conditions.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0169-2024·2024-01-03

    FDA recalls Asmanex asthma inhalation powder for improper storage conditions

    Cardinal Healthcare is recalling Asmanex Twisthaler inhalers (batch U027458) because they were exposed to temperatures outside their labeled storage conditions. The FDA classified this as a Class II recall due to the manufacturing deviation.

    Product
    ASMANEX — ASMANEX (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2024·2024-01-03

    Albuterol sulfate inhalation aerosol recalled for temperature storage deviation

    Cardinal Healthcare recalls albuterol sulfate inhalation aerosol batch MY7E nationwide due to exposure to temperatures outside labeled storage conditions. The precautionary recall affects 2 cartons.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0662-2024·2024-01-03

    Bowl & Basket Zero Calorie Sweetener recalled for undeclared aspartame

    Wakefern Foods Corp. is recalling Bowl & Basket Zero Calorie with Sucralose Sweetener due to undeclared aspartame and missing phenylalanine warning. The product poses a risk to consumers with phenylketonuria (PKU).

    Product
    Bowl & Basket Zero Calorie with Sucralose Sweetener 100 count, UPC 0-41190-06855-5, 12 retail cartons per wholesale case
    Category
    Food
    Distribution
    9 states
  • ModerateCPSC·24070·2023-12-28

    Simpson Gas Pressure Washers Recalled for Lithium Battery Burn Hazard

    FNA Group is recalling about 2,930 Simpson Gas Pressure Washers with Electric Start because the lithium battery in the electric start system can overheat and pose a burn hazard. Two reports of battery overheating have been received, but no injuries have been reported.

    Product
    Simpson Gas Pressure Washers with Electric Start
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2024·2023-12-27

    ACMI Roller Bar Electrodes Recall Due to Incorrect Pouch Labeling

    Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes due to incorrect pouch labels. Pouches are mislabeled as Right Angle Cutting Loop Electrodes but contain the correct Roller Bar product.

    Product
    ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0602-2024·2023-12-27

    ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification

    Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.

    Product
    ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0603-2024·2023-12-27

    Ice Cream Bar Recalled for Undeclared Food Dyes

    La Michoacana Rompope ice cream bars are being recalled due to undeclared Yellow #5, Yellow #6, and Red #40. The product was distributed only in Florida.

    Product
    ICE CREAM BAR, MICHOACANA, es...natural, ROMPOPE, Net. Wt. 6 Fl. Oz., Packaged in a plastic bag. Frozen.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0560-2024·2023-12-27

    Roche Cobas Interface Module Firmware May Cause Delayed Sample Processing

    Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.

    Product
    Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0586-2024·2023-12-27

    Exactech knee replacement inserts recalled for vacuum seal loss

    Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.

    Product
    Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-02
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0564-2024·2023-12-27

    Vero Biotech GENOSYL DS cassette recalled for manufacturing flow defect

    Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.

    Product
    VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0603-2024·2023-12-27

    ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification

    Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.

    Product
    ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0595-2024·2023-12-27

    CARDIOHELP-i Heart-Lung Support System not properly tested for leakage current

    The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.

    Product
    CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24068·2023-12-21

    TJX Foldable Wood and Rope Bistro Set Chairs Recall Due to Fall Hazard

    TJX is recalling about 29,000 foldable wood and rope bistro set chairs because the wooden frame can break or collapse when occupied, creating a fall hazard. The company has received eight reports of frame breakage, including six reports of minor injuries such as bruising and ankle strain.

    Product
    Foldable wood and rope bistro set chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide