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.

4401–4425 of 21589

  • ModerateFDA (Devices)·Z-1302-2022·2022-07-06

    Digital IVUS Catheter Recalled for Missing Contraindication Information

    Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1171-2022·2022-07-06

    Desmopressin Acetate Tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1288-2022·2022-07-06

    FDA recalls MAC laryngoscope sets due to packaging error

    Baxter Healthcare Corporation is recalling MAC laryngoscope devices due to a packaging error. The recall affects 99 units distributed worldwide.

    Product
    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·22753·2022-06-30

    Yamaha Kodiak 700 ATVs Recalled for Missing Load Limit Label

    Yamaha is recalling about 3,500 Model Year 2021 and 2022 Kodiak 700 ATVs because they are missing the "Maximum Loading Limit" label, which can result in unsafe trailer towing and crash hazards.

    Product
    Model Year 2021 and 2022 Kodiak 700 All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1348-2022·2022-06-29

    Wise Woman Herbals Sleepytime Glycerite Recalled for Yeast and Mold Contamination

    EarthLab Inc is recalling Wise Woman Herbals Sleepytime Glycerite due to elevated yeast and mold levels detected in microbial testing. Consumers should discontinue use.

    Product
    Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in formula. Dosage: 60 drops 1-4 times a day. Product is packaged in Amber Glass Boston Round bottle, Black serrated polypropylene dropper assembly with rubber bulb (2oz only) or Black serr
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1343-2022·2022-06-29

    Pedialyte with Immune Support Recalled for Potential Container Leakage

    Abbott Laboratories is recalling specific lots of Pedialyte with Immune Support in 1L containers due to potential leakage. Approximately 50,502 2-count cases are affected across 28 states.

    Product
    Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER, DEXTROSE*** Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
    Category
    Food
    Distribution
    28 states
  • ModerateFDA (Food)·F-1346-2022·2022-06-29

    Wise Woman Herbals Kava Capsules recalled for yeast and mold contamination

    EarthLab Inc is recalling Wise Woman Herbals Kava Capsules nationwide due to microbial contamination. Quality testing found yeast and mold counts that exceeded acceptable levels.

    Product
    Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Root), Dosage: 1 capsule up to 3 times per day day at 450mg Kava root. 90 counts per bottle. UPC 7 48840 14284 8. Kava Capsules older lots are packaged in 250cc Wide Mouth Amber Glass Packer, Black 45/400 PP ribbed ski
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1152-2022·2022-06-29

    FDA Recalls Clonidine Transdermal Patches for Delivery System Defect

    Mayne Pharma is recalling 1,440 cartons of Clonidine transdermal patches nationwide due to an out-of-specification defect in the release liner that could affect proper drug delivery.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·PHA-06242022·2022-06-24

    USDA Issues Public Health Alert for Ineligible Korean Catfish Stew Imports

    USDA FSIS issued a public health alert for frozen catfish stew imported from Korea, a country ineligible to export these products to the U.S.

    Product
    FSIS Issues Public Health Alert for Ineligible Siluriformes Products Imported from Korea
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateCPSC·22171·2022-06-23

    Loctek Fleximounts Overhead Garage Storage Racks Impact Injury Hazard

    Loctek is recalling FLEXIMOUNTS Overhead Garage Storage Racks because the U-shaped buckles on the supporting cables can fail, causing the rack to fall and create an impact injury hazard. The firm has received 18 reports of racks falling but no injuries have been reported.

    Product
    FLEXIMOUNTS Overhead Garage Storage Racks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22170·2022-06-23

    The Children's Place Baby Boy Rompers Recalled for Choking Hazard

    The Children's Place is recalling approximately 10,850 Baby Boy Dino Rompers and Baby Boy Camo Rompers Two Packs because metal snaps can detach, posing a choking hazard to infants. Two reports of snap detachment have been received with no injuries reported.

    Product
    Baby Boy Dino Rompers and Baby Boy Camo Rompers Two Pack
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22169·2022-06-23

    Troy-Bilt SpaceSavr Lawn Mowers Recalled for Fire Hazard

    MTD Products is recalling about 1,774 Troy-Bilt SpaceSavr walk-behind self-propelled lawn mowers because they can leak fuel when stored upright, posing a fire hazard. No injuries have been reported.

    Product
    Troy-Bilt SpaceSavr Walk-Behind Self-Propelled Lawn Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1141-2022·2022-06-22

    Homeopathic Drug Recall: Vaccinotoxinum Products Due to Manufacturing Violations

    Washington Homeopathic Products is recalling Vaccinotoxinum homeopathic remedies (lot numbers 2512K and 20280) distributed nationwide due to cGMP manufacturing deviations. The voluntary recall was initiated by the firm in May 2022.

    Product
    Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1159-2022·2022-06-22

    Artri King Reforzado con Ortiga Omega 3 Tablets Recalled as Unapproved Drug

    Walmart Inc is recalling Artri King Reforzado con Ortiga Omega 3 Tablets nationwide because the product was marketed as a drug without FDA approval. All lots are affected.

    Product
    Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1139-2022·2022-06-22

    Homeopathic Tuberculinum Drug Recalled for Manufacturing Practice Deviations

    Washington Homeopathic Products is recalling Tuberculinum homeopathic drug in multiple potencies due to manufacturing practice deviations. The voluntary recall affects product distributed nationwide.

    Product
    Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1138-2022·2022-06-22

    Syphilinum homeopathic drug recalled for manufacturing practice deviations

    Washington Homeopathic Products is recalling Syphilinum homeopathic products in multiple potencies due to current good manufacturing practice deviations. The affected products were distributed nationwide.

    Product
    Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1131-2022·2022-06-22

    Homeopathic drug Influenzinum recalled for manufacturing process deviations

    Washington Homeopathic Products is recalling Influenzinum in multiple potencies due to manufacturing process deviations. The recall affects approximately 6,400 units distributed nationwide.

    Product
    Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1125-2022·2022-06-22

    Homeopathic Drug Anthracinum Recalled Over Manufacturing Compliance Deviations

    Washington Homeopathic Products is recalling Anthracinum liquid pellets due to manufacturing process deviations. The voluntary recall affects 219 bottles distributed nationwide.

    Product
    Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1148-2022·2022-06-22

    Premium Nature Hand Sanitizer Recalled for Subpotent Ethanol Content

    AMS Packaging is recalling Premium Nature Instant Hand Sanitizer nationwide because FDA analysis found some bottles contain less ethanol than labeled.

    Product
    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1129-2022·2022-06-22

    Homeopathic Colibacillinum Drug Recall Due to Manufacturing Deviations

    Washington Homeopathic Products recalls Colibacillinum homeopathic drug products due to manufacturing practice deviations. The recall involves 206 bottles distributed nationwide; the manufacturer voluntarily initiated it in May 2022.

    Product
    Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1133-2022·2022-06-22

    Homeopathic Drug Morbillinum Recalled for Manufacturing Practice Deviations

    Washington Homeopathic Products is recalling Morbillinum in multiple potencies due to manufacturing practice deviations. No illnesses have been reported.

    Product
    Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1132-2022·2022-06-22

    Medorrhinum homeopathic drug recalled for manufacturing process deviations

    Washington Homeopathic Products recalled Medorrhinum liquid pellets nationwide due to deviations from manufacturing standards. The product was distributed in 49 glass amber bottles.

    Product
    Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1136-2022·2022-06-22

    Pyrogenium Homeopathic Remedy Recalled for Manufacturing Process Violations

    Washington Homeopathic Products is recalling Pyrogenium homeopathic remedies in multiple potencies due to current Good Manufacturing Practice (cGMP) deviations. The firm initiated this voluntary recall affecting 6,782 bottles distributed nationwide.

    Product
    Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1140-2022·2022-06-22

    Drug recall: Tuberculinum Bovinum due to manufacturing practice deviations

    Washington Homeopathic Products is recalling Tuberculinum Bovinum homeopathic remedy due to current good manufacturing practice deviations. No illnesses have been reported.

    Product
    Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1128-2022·2022-06-22

    Candida Parapsilosis homeopathic remedy recalled for manufacturing practice deviations

    Washington Homeopathic Products is recalling Candida Parapsilosis homeopathic remedies distributed nationwide due to manufacturing practice deviations. The recall affects 134 bottles under lot numbers 22315 and 26502.

    Product
    Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide