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.

3101–3125 of 21589

  • ModerateFDA (Drugs)·D-0175-2024·2024-01-03

    Dicyclomine Hydrochloride Tablets Recalled for Improper Storage Conditions

    Cardinal Healthcare is recalling Dicyclomine Hydrochloride 20 mg tablets due to temperature exposure outside labeled storage conditions. No illnesses have been reported.

    Product
    DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE 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-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 (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
  • ModerateFDA (Drugs)·D-0198-2024·2024-01-03

    Terconazole Vaginal Suppositories Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling Terconazole Vaginal Suppositories (batch 1014228A) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.

    Product
    TERCONAZOLE — TERCONAZOLE (TERCONAZOLE)
    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 (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-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 (Drugs)·D-0160-2024·2024-01-03

    Anoro Ellipta inhalation powder recalled for failed release testing defect

    GlaxoSmithKline is recalling 67,508 Anoro Ellipta inhalers nationwide because coarse particle mass failed release testing and was found out of specification. No illnesses have been reported.

    Product
    ANORO ELLIPTA — ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE)
    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-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-0164-2024·2024-01-03

    Allopurinol tablets recalled due to improper storage conditions

    Cardinal Healthcare is recalling Allopurinol 300 MG tablets (batch L100813) nationwide because products were exposed to temperatures outside their labeled storage conditions. Patients should consult their healthcare provider.

    Product
    ALLOPURINOL — ALLOPURINOL (ALLOPURINOL)
    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-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-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-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-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 (Drugs)·D-0187-2024·2024-01-03

    Birth control tablets recalled nationwide for temperature storage deviation

    Lillow oral contraceptive tablets (batch A5921) have been recalled nationwide by Cardinal Healthcare due to exposure to temperatures outside labeled storage conditions.

    Product
    Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0197-2024·2024-01-03

    Prescription drug SPIRIVA recalled for temperature storage deviation

    SPIRIVA (tiotropium bromide) inhalation powder batch 104440 is being recalled nationwide due to exposure to temperatures outside the product's labeled storage conditions during manufacturing.

    Product
    SPIRIVA — SPIRIVA (TIOTROPIUM BROMIDE)
    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
  • 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-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 (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