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.

926–950 of 2769

  • LowFDA (Drugs)·D-1129-2018·2018-09-05

    Mayne Pharma Recalls Oxycodone and Acetaminophen Tablets Due to Labeling Error

    Mayne Pharma is recalling 6,456 bottles of Oxycodone and Acetaminophen Tablets due to a lot number labeling error on the primary container.

    Product
    Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1171-2018·2018-09-05

    Validus Recalls Rocaltrol Oral Solution Due to Lower Potency

    Validus Pharmaceuticals is recalling 696 bottles of Rocaltrol (calcitriol) Oral Solution because testing showed lower than expected potency.

    Product
    Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1909-2018·2018-09-05

    Morton Natural Sea Salt Recalled for Iodized Salt Packaging Error

    Morton Salt Inc. is recalling 22,284 units of Morton Natural Sea Salt because iodized sea salt was packaged in the wrong containers.

    Product
    MORTON NATURAL SEA SALT ALL PURPOSE***NET WET 26 OZ (1 LB 10 OZ) 737 g***Nutrition Facts***INGREDIENTS: SEA SALT PRODUCT OF BAHAMAS***MORTON SALE, INC, CHICAGO, IL 60606***QUESTIONS? CALL 1-800-789-SALT (7258)
    Category
    Food
    Distribution
    9 states
  • LowFDA (Devices)·Z-2919-2018·2018-08-29

    Euro Diagnostica Anti-Ro ELISA Kits Recalled for Incorrect Labeling

    Euro Diagnostica is recalling Anti-Ro (SS-A) ELISA kits due to incorrect labeling. The label incorrectly states 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin'.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases,
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2920-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling Anti-Cardiolipin ELISA kits due to incorrect labeling. The kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoanti
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1112-2018·2018-08-29

    Mylan Recalls Diltiazem HCl Extended-release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, 120 mg, due to out-of-specification impurities.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2922-2018·2018-08-29

    Euro Diagnostica Scl-70 ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling four Scl-70 ELISA kits due to incorrect distribution labeling. The kits were manufactured by DiaSorin but incorrectly labeled as manufactured by them.

    Product
    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation.
    Category
    Medical Device
    Distribution
    1 state
  • 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 (Devices)·Z-2921-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits due to an incorrect distribution label. The kits were distributed in Minnesota.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibod
    Category
    Medical Device
    Distribution
    1 state
  • 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 sect
    Category
    Medical Device
    Distribution
    6 states
  • 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-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 (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 (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 (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 Gravity,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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