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.

5351–5375 of 21589

  • 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-0831-2021·2021-10-06

    Aveeno Protect + Refresh Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Aveeno Protect + Refresh sunscreen weightless spray SPF 60 nationwide due to cGMP (current good manufacturing practice) deviations.

    Product
    Aveeno Protect + Refresh sunscreen weightless spray with oat 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 08558 UPC 3 8137-119462 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0877-2021·2021-10-06

    Washington Homeopathic Products Quebracho 4C Fever Medicine Recall

    Washington Homeopathic Products is recalling Quebracho 4C Fever homeopathic medicine (Lot #28930, expiration 8/17/2026) distributed nationwide due to out-of-specification test results from identification testing.

    Product
    Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0861-2021·2021-10-06

    Washington Homeopathic Products Haloderm Homeopathic Blend Recalled

    Washington Homeopathic Products is recalling Haloderm Homeopathic Blend due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Class II Drug Recall

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Beach Defense water+sun protection sunscreen spray SPF 70 due to cGMP (current Good Manufacturing Practice) deviations. Approximately 411,180 cans distributed nationwide are affected.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2570-2021·2021-10-06

    Olympus BF-XT160 Bronchovideoscope Reprocessing Instructions Updated for FDA Compliance

    Olympus Corporation is issuing updated reprocessing instructions for 293 BF-XT160 bronchovideoscopes to comply with FDA 2015 guidance. Healthcare facilities should implement the new sterilization and disinfection procedures.

    Product
    BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
    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-0868-2021·2021-10-06

    Verbena Officinalis Homeopathic Pills Fail Identification Testing

    Washington Homeopathic Products is recalling 3 bottles of Verbena Officinalis 6X (Lot #29060, expiration 8/17/2026) distributed nationwide due to out-of-specification test results in identification testing.

    Product
    Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, WHP Homeopathic Medicine, Washington Hoemopathis Producs, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0866-2021·2021-10-06

    Humulus 6X, 15X Homeopathic Pills Recalled for Failed Testing

    Washington Homeopathic Products is recalling Humulus 6X and 15X homeopathic pills distributed nationwide due to out-of-specification test results from identification testing.

    Product
    Humulus 6X, 15X, Sucrose/Lactose Pills, 6X Packaged as a) 4dr, UPC 7 40640 33969 5; 15X Packaged as b) 4 dr; WHP Homeopathic Medicine. Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2021·2021-10-06

    Lyrica CR 330 mg Tablets Recalled for Failed Dissolution

    Viatris is recalling Lyrica CR (pregabalin) 330 mg extended-release tablets nationwide due to failed dissolution specifications that may reduce drug effectiveness.

    Product
    Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0872-2021·2021-10-06

    Althaea Officinalis Homeopathic Pills Recall Due to Failed Identity Testing

    Washington Homeopathic Products is recalling Althaea Officinalis 6X Irritable Bladder Sucrose/Lactose Pills distributed nationwide because test results failed to confirm the product's identity using HPTLC analysis.

    Product
    Althaea Officinalis 6X, 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-0850-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 60+) due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and affects nationwide distribution in the US.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255
    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 (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-0876-2021·2021-10-06

    Washington Homeopathic Products Cistus Canadensis Drops Recall

    Washington Homeopathic Products is recalling Cistus Canadensis 5X Coldness 20% Alcohol drops (15ml and 50ml bottles) distributed nationwide due to out-of-specification identification test results.

    Product
    Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ml; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0996-2021·2021-09-29

    Sysco Atlanta Sweet Potato Dice Recalled for Improper Temperature Storage

    Sysco Atlanta is recalling Imperial Fresh Potato Sweet Dice shipped to GA, NC, and TN due to improper temperature storage that may have rendered the product unsafe to consume.

    Product
    IMPERIAL FRESH POTATO SWEET DICE 1/2, 4/5lbs Plastic overwrap tray
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0828-2021·2021-09-29

    Betadine Povidone-Iodine Solution Swabstick recalled for subpotent drug

    Avrio Health L.P. is recalling Betadine Solution Swabstick in single and three-count packages nationwide because the product is subpotent—meaning it contains less active ingredient than specified. Consumers should stop using affected lots and consult their healthcare provider if needed.

    Product
    BETADINE — BETADINE (POVIDONE-IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2021·2021-09-29

    Glenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2021·2021-09-29

    Ad-Tech TECH ATTACH Cable Recalled for Incorrect Label Information

    Ad-Tech Medical recalled its Lightweight TECH ATTACH Cable due to incorrect labels on affected units. The cables are designed to connect electrodes to third-party monitors and stimulators.

    Product
    Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2520-2021·2021-09-29

    Decompression Needle Recall Due to Incorrect Instructions for Use

    North American Rescue is recalling 51,424 units of 10 ga ARS Decompression Needles due to incorrect Instructions for Use. Affected parties should stop using and contact manufacturer.

    Product
    10 ga ARS Decompression Needle, Part Number ZZ-0298
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0993-2021·2021-09-29

    Fleischmann's Compressed Fresh Yeast Recall Due to Temperature Control

    Sysco Atlanta is recalling Fleischmann's Yeast Compressed Fresh in 24/1 lb packages because the product was not stored at appropriate temperatures, creating potential food safety risk.

    Product
    FLEISCHMANN'S YEAST COMPRESSED FRESH ESL 24/1lbs Paper/Foil overwrap
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0818-2021·2021-09-29

    Hydroquinone Skin Bleaching Cream Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.

    Product
    HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0816-2021·2021-09-29

    Valproic Acid Oral Solution recalled for microbial contamination

    Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1002-2021·2021-09-29

    Alfalfa Sprouts Recall Due to Improper Temperature Storage

    Sysco Atlanta is recalling Sunny Creek and Bloomsbury Organic Farm alfalfa sprouts sold in Georgia, North Carolina, and Tennessee because the product was not held at appropriate temperatures and may be unsafe to consume.

    Product
    Alfalfa Sprouts 12/4oz Plastic container, sold under the the brand names of: Sunny Creek UPC 7 38015 77740 1 SUNNY CREEK FARM Tryon, NC 28782 and BLOOMSBURY ORGANIC FARMKEEP REFRIGERATED
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0807-2021·2021-09-29

    Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.

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