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.

401–425 of 3531

  • ModerateFDA (Drugs)·D-0045-2025·2024-11-20

    Hydralazine Tablets Recalled Due to Failed Impurities and Degradation Testing

    Hydralazine HCl Tablets 25mg are recalled nationwide due to failed impurities and degradation specifications. The recall affects approximately 25,814 tablets distributed by Avet Pharmaceuticals and MAJOR Pharmaceuticals.

    Product
    Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0123-2025·2024-11-20

    Berkeley Springs Water Recalled for Coliform Contamination

    Berkeley Club Beverages is recalling Berkeley Springs Water Purified and Distilled due to coliform contamination detected during testing. The recall affects 1,304 bottles distributed in West Virginia, Maryland, and Virginia.

    Product
    Berkeley Springs Water Purified , Berkeley Springs Water Distilled , One Gallons & Five Gallons, Plastic, 6 gallons in one case and1 individual 5 Gallon, Codes 090326,090426,090526,090626.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0043-2025·2024-11-20

    Lanthanum Carbonate 1000mg Chewable Tablets Recalled for Broken and Crushed Tablets

    Cipla USA is recalling Lanthanum Carbonate Chewable Tablets, 1000mg due to complaints of crushed and broken tablets. The recall affects 1,875 boxes distributed nationwide.

    Product
    Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0363-2025·2024-11-20

    Karl Storz Irrigation Tubing Recalled for Unapproved Label Use

    Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 because its label claims an intended use that the FDA has not approved for U.S. distribution.

    Product
    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0460-2025·2024-11-20

    FDA Recalls MEERA CL Mobile Operating Tables for Unintended Movement Stops

    Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0350-2025·2024-11-20

    Medline arthroscopy surgical kits recalled for incomplete packaging seal

    Medline Industries is recalling 80 arthroscopy surgical convenience kits due to incomplete packaging seals. The affected lot numbers are 24GBI464 and 24HBO800.

    Product
    ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0046-2025·2024-11-20

    Perio Maintenance Rinse Recalled for Subpotent Stannous Fluoride Concentration

    Keystone Industries is recalling Perio Maintenance Rinse due to subpotency—the stannous fluoride concentration is below specifications. Affected lots were distributed nationwide.

    Product
    Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2025·2024-11-13

    OTC cough and congestion medication recalled for crystallization

    Denison Pharmaceuticals is recalling its Maximum Strength Cough and Chest Congestion medication due to crystallization in bottles. The product, distributed by Genexa Inc., may contain chunks, graininess, or crystal substances that affect uniformity.

    Product
    MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK — MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0114-2025·2024-11-13

    MySyrup Sugar Free Hazelnut Syrup Recalled Due to Missing Production Records

    MySyrup Sugar Free Hazelnut Syrup (556 jugs) is being recalled nationwide because production records are missing for this acidified product, preventing verification of proper processing procedures.

    Product
    MySyrup Sugar Free Hazelnut Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural and artificial flavor, potassium sorbate and sodium benzoate (to protect flavor), sucralose, acesulfame potassium, cit
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0284-2025·2024-11-13

    Canon Medical PET-CT System Software Malfunction Prevents Image Reconstruction

    27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.

    Product
    Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·F-0111-2025·2024-11-13

    MySyrup Sugar Free Almond Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Almond Syrup due to missing production records. The recall affects 212 jugs with batch numbers and expiration dates from August 2023 through December 2024.

    Product
    MySyrup Sugar Free Almond Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, Madagascar vanilla extract, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame pot
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2025·2024-11-13

    Dapsone Gel 7.5% recalled nationwide due to crystallization

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% due to crystallization. The voluntary recall covers 6,048 pumps distributed nationwide in the United States.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2025·2024-11-13

    Adult Cap-ONE Biteblock devices recalled for expired product distribution

    Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.

    Product
    Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2025·2024-11-13

    X-ray System Software May Fail to Display Images During Mode Switching

    SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.

    Product
    SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0116-2025·2024-11-13

    MySyrup Sugar Free Peppermint Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Peppermint Syrup (68 fl oz bottles) nationwide due to missing production records documenting the acidification process. No illnesses have been reported.

    Product
    MySyrup Sugar Free Peppermint Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame potassium, citric acid. Ma
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2025·2024-11-13

    Intra-Aortic Balloon Catheters Recalled for Packaging Label Discrepancy

    Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.

    Product
    MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0119-2025·2024-11-13

    Oregon Orchards Banana Smoothie Mix recalled for inadequate acidification documentation

    My Chai Inc is recalling Oregon Orchards Banana Smoothie Mix nationwide due to insufficient production records proving proper acidification. Consumers should not consume the product.

    Product
    Oregon Orchards Banana Smoothie Mix. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Sugar, banana puree, water, natural flavor, citric acid, xanthan gum, sodium benzoate (to help protect flavor-1/10 of 1%), vanilla
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0276-2025·2024-11-06

    KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use

    King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0258-2025·2024-11-06

    17-OH Progesterone ELISA Kit Recalled for Labeling Discrepancy

    DRG International is recalling 504 units of its 17-OH Progesterone ELISA kit (Model EIA-1292) due to mismatched control acceptance ranges between the Certificate of Analysis and component labels, causing test failure.

    Product
    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0070-2025·2024-11-06

    International Delight Peppermint Mocha Mislabeled as Zero Sugar Product Recall

    DANONE US LLC is recalling Home Alone International Delight Peppermint Mocha Zero Sugar beverages because the product is labeled as zero sugar but actually contains sugar. The recall affects 1,799 cases distributed across multiple states.

    Product
    Home Alone International Delight Peppermint Mocha Zero Sugar, 32oz plastic bottle, 6 bottles per case. Refrigerated.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0260-2025·2024-11-06

    Surgical tracking device patient labels show incorrect expiration date

    Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.

    Product
    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a
    Category
    Medical Device
    Distribution
    5 states
  • ModerateNHTSA·23V016000·2024-11-01

    2022 Subaru WRX Owner's Manual Contains Incorrect High Beam Assist Instructions

    Subaru is recalling 2022 WRX vehicles with Eyesight because the owner's manual contains incorrect instructions for adjusting the High Beam Assist function. Owners will receive a corrected manual insert by mail.

    Product
    SUBARU — 2022 SUBARU WRX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·25026·2024-10-31

    Humane Charge Case Accessory for Ai Pin Recalled for Lithium Battery Fire Hazard

    Humane Inc. is recalling about 10,500 Charge Case Accessory units for the Ai Pin because the lithium battery can overheat and pose a fire hazard. The company has received one report of a charge case overheating and melting during charging, though no injuries or property damage have been reported.

    Product
    Humane Charge Case Accessory for Ai Pin
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2025·2024-10-30

    Drug injection product recalled due to manufacturing quality violations

    Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0015-2025·2024-10-30

    Sterile drug injection bags recalled for manufacturing process violations

    Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl injection due to manufacturing process violations. The product was distributed to 125 healthcare facilities nationwide. The recall was concluded in August 2025.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
    Category
    Drug
    Distribution
    Distributed nationwide