The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

951–975 of 2741

  • LowFDA (Food)·F-1958-2018·2018-08-29

    Gourmet International Recalls LItaly Sparkling Sour Cherry Juice Drink

    Gourmet International Inc. is voluntarily recalling LItaly Sparkling Sour Cherry Juice Drink due to packaging concerns and reports of leaking caps.

    Product
    SPARKLING SOUR CHERRY JUICE DRINK, 6/34 oz., glass bottles
    Category
    Food
    Distribution
    8 states
  • LowFDA (Drugs)·D-1099-2018·2018-08-22

    FDA Recalls Contrave Tablets Due to Punctured Bottle Complaints

    Orexigen Therapeutics is recalling 95,296 bottles of Contrave extended-release tablets due to customer complaints of punctures in the bottles.

    Product
    CONTRAVE — CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1076-2018·2018-08-22

    Acne Treatment Pads Recalled for Subpotent Salicylic Acid Levels

    Huijing (Shanghai) Bio-tech Co., Ltd. is recalling Acne Treatment Pads because the active ingredient level does not match the label.

    Product
    Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2749-2018·2018-08-22

    Richard-Allan Scientific Recalls Mislabeled EZ Single Cytofunnel Brown Units

    Richard-Allan Scientific is recalling 1,039 cases of EZ Single Cytofunnel Brown units due to mislabeling. The recall is voluntary and nationwide.

    Product
    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1831-2018·2018-08-22

    Prana Biovegan Organic Dried Figs Recalled for Insects

    Prana Biovegan Inc. is recalling Organic Dried Figs because the product may contain insects. The recall affects specific lots distributed to Pennsylvania and Massachusetts.

    Product
    Organic Dried Figs 6X16oz (454g), UPC 8 77693 00850 3
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1813-2018·2018-08-22

    Confidence Glucosamine Plus Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Glucosamine Plus tablets because they contain undeclared ingredients, including Hydroxypropyl Methylcellulose and Titanium Dioxide.

    Product
    FP0392, Confidence, Glucosamine Plus, with White Willow Bark & Boswella, 90 Extended Release Tablets, UPC# 8 10891 02253 7
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2786-2018·2018-08-22

    Clarity 10SG Urinalysis Strips Recalled for Analyzer Incompatibility

    Clarity Diagnostics is recalling specific lots of Clarity 10SG Urinalysis Strips because they lack a Canister Code Bar Code Label, making them incompatible with Clarity Urocheck 120 Urine Analyzers.

    Product
    Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1816-2018·2018-08-22

    Confidence Glucosamine Plus Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Glucosamine Plus tablets because they contain undeclared ingredients, including Hydroxypropyl Methylcellulose and Titanium Dioxide.

    Product
    FP0391 Confidence, Glucosamine Plus, With Hyaluronic Acid + Curcumin & Boswellia, 60 Extended Release Tablets, UPC: 8 92483 00106 9
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2827-2018·2018-08-22

    Tosoh Bioscience Recalls AIA Analyte Application Manual CDs

    Tosoh Bioscience is recalling 9 AIA Analyte Application Manual CDs due to unapproved product labeling. The CDs were distributed to six US states.

    Product
    Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference…
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-1035-2018·2018-08-15

    Baxter Recalls Levofloxacin Injection Due to High Potency Levels

    Baxter Healthcare is recalling specific lots of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1768-2018·2018-08-15

    Kraft Heinz Recalls Asian Style Sesame Ginger Dressing Due to Spoilage

    Kraft Heinz is recalling 19,560 cases of Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing due to premature spoilage caused by lactic acid producing bacteria.

    Product
    Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing. 12 oz glass bottle, 6 bottles per case Shelf Stable and Refrigerate After Opening UPC 0021000068876
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1755-2018·2018-08-15

    Stavis Seafoods Recalls Decomposed Vacuum Packed Ahi Tuna Saku

    Stavis Seafoods is recalling vacuum-packed Ahi Tuna Saku because the product is decomposed. The recall covers specific lots distributed to multiple states.

    Product
    Ocean Delight Individually Vacuum Packed AHI TUNA SAKU, 8-12 oz. NET WT. 10 LB (4.54 kg) and 12-16 oz. NET WT. 22LB (9.98 kg), Carbon Monoxide Treated, DISTRIBUTED BY: Stavis Seafoods, WILD CAUGHT, PRODUCT OF SRI LANKA
    Category
    Food
    Distribution
    13 states
  • LowFDA (Drugs)·D-1047-2018·2018-08-15

    Right Value Drug Stores Recalls Testosterone Pellets Due to Labeling Error

    Right Value Drug Stores is recalling 4,800 Testosterone 200 mg Pellets because the label contains an incorrect expiration date.

    Product
    Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1050-2018·2018-08-08

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Stability Test Failure

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because an out-of-specification result was found in a stability study. The product was distributed throughout the United States.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-2573-2018·2018-08-08

    Diamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 505 units of the Is-Mumps IgG Enzyme Immunoassay Test Kit because a gel-like contaminant may affect product performance.

    Product
    Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-2574-2018·2018-08-08

    Diamedix EBV Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 147 units of the Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit due to a gel-like contaminant that may affect product performance.

    Product
    Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Drugs)·D-1031-2018·2018-08-08

    Renaissance Lakewood Recalls Fluconazole Injection Bags Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 3,000 bags of Fluconazole Injection due to elevated sodium chloride and water vapor levels.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1032-2018·2018-08-08

    Fluconazole Injection Recalled for Elevated Water Vapor Levels

    Renaissance Lakewood, LLC is recalling Fluconazole Injection bags due to elevated water vapor levels. The recall covers 3,664 bags distributed nationwide and in Puerto Rico.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2598-2018·2018-08-08

    BD FACS Universal Loader Recalled for Insufficient Locking Mechanism

    Becton, Dickinson and Company is recalling 8 BD FACS Universal Loader devices because the solenoid plunger tip is too short to lock securely during use.

    Product
    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It…
    Category
    Medical Device
    Distribution
    6 states
  • LowUSDA FSIS·067-2018·2018-08-06

    StoneRidge Pork and Beef Bologna Recalled for Misbranding

    StoneRidge Wholesale Division LLC is recalling approximately 656 pounds of pork and beef bologna products because they contain undeclared sodium nitrite and sodium erythorbate.

    Product
    StoneRidge Wholesale Division LLC — Recall Notification Report 067-2018 (Pork and Beef Bologna Products)
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0990-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues

    Aidarex Pharmaceuticals is recalling 11 bottles of Enalapril Maleate 2.5mg because out-of-specification degradation products were found during stability testing.

    Product
    Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2551-2018·2018-08-01

    ImplantDirect Dental Implants Recalled for Incorrect Vial Label Part Number

    Implant Direct Sybron Manufacturing is recalling 124 units of ImplantDirect dental implants because the main vial label lists an incorrect part number, although the cap label is correct.

    Product
    ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Drugs)·D-0980-2018·2018-08-01

    Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

    Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, 5 mg, due to out-of-specification degradation products.

    Product
    Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1664-2018·2018-08-01

    Orca Bay Foods Recalls Decomposed Wild Mahi-Mahi Loins

    Orca Bay Foods LLC is recalling 17 cases of decomposed wild-caught mahi-mahi loins sold in Florida, North Carolina, and Maryland.

    Product
    Consumer Packaging: WELLSLEY FARM WILD CAUGHT MAHI-MAHI LOINS, UPC: 8 88670 00983 3, plastic 2lb retail bag, Keep Frozen. Master Carton: BJ s Wholesale Club Wild Mahi Mahi Loins Skinless Bone Out 16/2Lb. VP Bags. NET WT. 32 LB. Item Code: 32272, UPC: 0 29714 32727 2. Product…
    Category
    Food
    Distribution
    3 states