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.

3226–3250 of 3531

  • ModerateFDA (Devices)·Z-0033-2022·2021-10-13

    Medical Device Calibrator Kit Recall for Incorrect Labeling

    FDA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled calibrator vials in Lot 00681Y600. The labeling error prevents the instrument from completing calibration successfully.

    Product
    Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
    Category
    Medical Device
    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 (Food)·F-0008-2022·2021-10-06

    RC Cola 12 oz cans recalled for off flavor and aroma

    Keurig Dr Pepper is recalling RC Cola 12 oz aluminum cans (12-pack) due to consumer complaints of off flavor and aroma. The affected product was distributed to multiple states.

    Product
    Rc Cola 12 Oz (355 mL) packaged in an aluminum can 12 can to a pack
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0880-2021·2021-10-06

    Z-107 Formula Soft Tissue Healing Recalled for Out-of-Specification Test Results

    Washington Homeopathic Products, Inc. is recalling Z-107 Formula Soft Tissue Healing due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0871-2021·2021-10-06

    Washington Homeopathic Products Kali Sulphuricum fails identification test

    Washington Homeopathic Products is recalling Kali Sulphuricum 3X homeopathic medicine nationwide because identification testing using HPTLC analysis produced out-of-specification results.

    Product
    Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Use Only. Manufactured by Washington Homeopathic Products 260JR hawvermale Way Berkeley Springs WV 25411.
    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-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-0858-2021·2021-10-06

    ZTE-105 Formula Gentle Detoxing Recall Due to Failed Identification Testing

    Washington Homeopathic Products is recalling ZTE-105 Formula Gentle Detoxing due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2571-2021·2021-10-06

    BF-P180 EVIS EXERA II Bronchovideoscope Reprocessing Instructions Validation Recall

    Olympus Corporation issued updated reprocessing instructions for 1,177 BF-P180 EVIS EXERA II Bronchovideoscopes to ensure compliance with FDA validation standards for medical device sterilization.

    Product
    BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0898-2021·2021-10-06

    Sodium Phenylbutyrate Powder Recalled for Impurity Specification Failures

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.

    Product
    SODIUM PHENYLBUTYRATE — SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE)
    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
  • ModerateFDA (Drugs)·D-0843-2021·2021-10-06

    Neutrogena Invisible Daily Defense Body Spray Sunscreen Recall

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Invisible Daily Defense body spray sunscreen (SPF 60+) due to cGMP deviations. The recall affects approximately 88,380 cans distributed nationwide.

    Product
    Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2
    Category
    Drug
    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 (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-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 (Drugs)·D-0879-2021·2021-10-06

    Z-103 GU DETOXING Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Z-103 GU DETOXING, a 1000ml homeopathic medicine containing 20% alcohol, due to out-of-specification test results on identification testing using HPTLC analysis.

    Product
    Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Ver
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0869-2021·2021-10-06

    Viola Odorata Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Viola Odorata homeopathic medicine (Lot #29057, expiration 8/17/2026) distributed nationwide because identification testing using HPTLC analysis returned out-of-specification results.

    Product
    Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged in a) 2 Dram; 10X Packaged in b) 2 Dram; 12X Packaged in c) 2 Dram; d) 4 Dram; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2568-2021·2021-10-06

    Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance

    Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.

    Product
    BF-P60 OES Bronchofiberscope, Model No. BF-P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0833-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer is recalling Neutrogena Beach Defense water + sun protection sunscreen spray in two sizes (6.5 oz and 8.5 oz) nationwide due to current good manufacturing practice (cGMP) deviations.

    Product
    Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed
    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 (Devices)·Z-2572-2021·2021-10-06

    Olympus BF-1T180 Bronchovideoscope Reprocessing Instructions Updated

    Olympus Corporation is issuing updated reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope to comply with FDA 2015 guidance on medical device reprocessing validation.

    Product
    BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0885-2021·2021-10-06

    ZTE-1034 Formula Antimicrobial Bowel homeopathic medicine recall

    Washington Homeopathic Products, Inc. is recalling ZTE-1034 Formula Antimicrobial Bowel (1000ml bottles) due to out-of-specification test results in identification testing. The product was distributed nationwide.

    Product
    ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0857-2021·2021-10-06

    Aconitum nap Fear Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Aconitum nap Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing. The recall affects 562 bottles across multiple potencies and lot 26198.

    Product
    Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol HPUS: 24X, packaged in 50 mL containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    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 (Food)·F-1021-2021·2021-10-06

    HEB Jumbo Stuffed Shells Recalled for Possible Metal Contamination

    HEB Jumbo Stuffed Shells filled with ricotta and romano cheese may contain metal fragments. The product was distributed in Texas under item number 796702 with a sell-by date of 07/27/2022.

    Product
    HEB Jumbo Stuffed Shells; Jumbo Shells Filled with Creamy Ricotta and Romano Cheese; NET WT. 22 OZ (1 LB 6OZ) 624g
    Category
    Food
    Distribution
    1 state