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.

5326–5350 of 21589

  • ModerateFDA (Drugs)·D-0846-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recall Due to cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 70) nationwide due to cGMP deviations. This is a voluntary recall initiated by the manufacturer.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), a) NET WT. 6.5 OZ. (184 g) (UPC 0 86800 87274 0) and b) NET WT. 8.5 OZ. (240 g) (UPC 0 86800 10048 5) aerosol can, Distribut
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2485-2021·2021-10-06

    Blood collection tubes recalled due to potential clotting defect

    Greiner Bio-One North America is recalling VACUETTE blood collection tubes (6 ml K2E) because they may experience a clotting issue. Approximately 962,400 tubes were distributed across 15 US states and Canada.

    Product
    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0835-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Class II Recall

    Johnson & Johnson Consumer, Inc. is recalling 678,384 cans of Neutrogena COOLDRY SPORT sunscreen spray nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858, UPC 0 86800 10037 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1024-2021·2021-10-06

    Crunchy Cones ice cream recalled for undeclared sulfites

    Borinquen Cones of Puerto Rico is recalling Crunchy Cones Mix Choco-Vanilla because the product label does not declare the presence of sulfites, which may pose a risk to consumers with sulfite sensitivity.

    Product
    Crunchy Cones, Mix Choco-Vanilla, 12, NET WT 40oz (113g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0888-2021·2021-10-06

    ZTE 1015 Formula Homeopathic Product Recall for Out-of-Specification Test Results

    Washington Homeopathic Products is recalling ZTE 1015 Formula due to out-of-specification test results from identification testing. The product failed HPTLC analysis.

    Product
    ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2593-2021·2021-10-06

    uMI 550 PET Imaging System Software Workflow May Occasionally Freeze

    The uMI 550 medical imaging system may occasionally freeze during the EXAM acquisition workflow when a PET scan is canceled. This can disrupt clinical operations.

    Product
    uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2021·2021-10-06

    Althaea 6X Irritable Bladder Homeopathic Drops Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder drops (Lot #29377) distributed nationwide because identification testing via HPTLC analysis produced out-of-specification results.

    Product
    Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0863-2021·2021-10-06

    Althaea Officinalis 4X Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea Officinalis 4X, Iritable Bladder homeopathic medicine (Lot # 29377, Exp 8/17/2026) distributed nationwide because testing results failed to meet specifications for product identification.

    Product
    Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0873-2021·2021-10-06

    Washington Homeopathic Products Althaea 6X Bladder Pills Recalled

    Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder Pills due to out-of-specification test results from identification testing. Ten bottles nationwide have been affected.

    Product
    Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0895-2021·2021-10-06

    Washington Homeopathic Products Aconitum Napellus 12X Fear Recall

    Washington Homeopathic Products is recalling Aconitum Napellus 12X Fear homeopathic medicine due to out-of-specification test results from identification testing.

    Product
    Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0886-2021·2021-10-06

    ZTE-1035 Homeopathic Formula Recalled for Test Failures

    Washington Homeopathic Products is recalling ZTE-1035 Formula, an antimicrobial homeopathic combination product, due to out-of-specification test results for identification testing based on HPTLC analysis.

    Product
    ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiz
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2594-2021·2021-10-06

    uEXPLORER PET/CT System Workflow Freeze Recall

    The uEXPLORER PET/CT System is being recalled because the EXAM acquisition workflow may freeze after canceling a PET scan. Affected systems may experience workflow interruptions during diagnostic imaging.

    Product
    uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0862-2021·2021-10-06

    Cedar Fever Drops Homeopathic Drug Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Cedar Fever Drops due to out-of-specification test results from identification testing. The affected product was distributed nationwide.

    Product
    Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder allerges, Manufactured for Peoples RX, 3801 S Lamar, Austin, TX 78704. UPC 7 40640 64166 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0891-2021·2021-10-06

    Aconitum Napellus Fear Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling 562 bottles of Aconitum Napellus Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing.

    Product
    Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alcohol HPUS: 6X, 10X, packaged in 30mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 10X, 12X, 30X, packaged in 50mL containers Aconitum Napellus Fear
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0854-2021·2021-10-06

    Valproic Acid Oral Solution Recalled for Microbial Contamination

    American Health Packaging is recalling Valproic Acid Oral Solution due to potential microbial contamination in liquid sugar batches used during manufacturing. The affected product was distributed nationwide.

    Product
    Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0865-2021·2021-10-06

    Washington Homeopathic Cistus Canadensis pills fail quality identification testing

    Washington Homeopathic Products is recalling Cistus Canadensis homeopathic pills in multiple potencies because they failed out-of-specification identification testing. The recall affects 17 bottles distributed nationwide.

    Product
    Cistus Canadensis 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Packaged as a) 1 OZ, UPC 7 40640 28177 2, b) 4 dr, UPC 7 40640 28173 4; 10X Packaged as c) 4 dr; 15X Packaged as d) 1 OZ; 30X Packaged as e) 2 Dram, UPC 7 40640 28171 0, f) 4 dr, UPC 7 40640 28175 8; WHP Hom
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·22004·2021-10-06

    Hobby Lobby White Wood Stools Recalled for Fall and Injury Hazards

    Hobby Lobby is recalling about 14,000 White Wood Stools sold nationwide from June through July 2021 because the stools can break during use, posing fall and injury hazards. Hobby Lobby has received seven reports of the stool breaking, including six resulting in minor injuries.

    Product
    White Wood Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0860-2021·2021-10-06

    Yeast Guard Blend Homeopathic Medicine Fails Identification Testing

    Washington Homeopathic Products is recalling Yeast Guard Blend homeopathic medicine because test results show it does not meet specification requirements for identification testing.

    Product
    Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic Medicine, For Manufacturing Use Only. 1.957 kg Lactose, Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2021·2021-10-06

    Althaea 30X Homeopathic Pills Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea 30X Irritable Bladder sucrose/lactose pills (Lot #29377, expiration 8/17/2026) distributed nationwide because testing revealed out-of-specification results for product identification.

    Product
    Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0832-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson is recalling Neutrogena COOLDRY SPORT sunscreen spray SPF 30 in two sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 469,764 cans.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skill
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0855-2021·2021-10-06

    Hydroquinone 4% Skin Bleaching Cream Recalled for Specification Failure

    Monarch PCM, LLC is recalling Hydroquinone USP 4% Skin Bleaching Cream because the finished product did not meet USP (United States Pharmacopeia) specifications. The recall affects 11,419 tubes distributed in Tennessee.

    Product
    HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
    Category
    Drug
    Distribution
    1 state