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.

1276–1300 of 2741

  • LowFDA (Devices)·Z-2212-2017·2017-06-07

    Acumedia Sabouraud Dextrose Agar Recalled for Incorrect Storage Labeling

    Acumedia is recalling 10 units of Sabouraud Dextrose Agar in Illinois due to incorrect storage temperature information on the label.

    Product
    Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2203-2017·2017-06-07

    Cell Marque Recalls Her2/Neu Reagent Due to Missing Export Labeling

    Cell Marque is recalling Her2/Neu (c-erbB-2) reagents because they were not labeled as 'For Export Only' as required by law.

    Product
    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2208-2017·2017-06-07

    Cell Marque Recalls Varicella Zoster Virus Reagent Due to Labeling Error

    Cell Marque is recalling Varicella Zoster Virus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2204-2017·2017-06-07

    Cell Marque Recalls Her2/Neu Reagents for Missing Export Labeling

    Cell Marque is recalling Her2/Neu (EP3) reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2205-2017·2017-06-07

    Cell Marque Recalls Herpes Simplex Virus I Reagents Due to Labeling Error

    Cell Marque is recalling Herpes Simplex Virus I reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0868-2017·2017-06-07

    Sandoz Recalls Subpotent Amoxicillin and Clavulanate Potassium Tablets

    Sandoz Inc is recalling 4,464 bottles of Amoxicillin and Clavulanate Potassium tablets found to be subpotent in clavulanic acid.

    Product
    AMOXICILLIN AND CLAVULANATE POTASSIUM — AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Devices)·Z-2201-2017·2017-06-07

    Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling

    Cell Marque is recalling 8 units of Estrogen Receptor reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2202-2017·2017-06-07

    Cell Marque Recalls H. pylori Reagent Due to Missing Export Labeling

    Cell Marque is recalling five units of H. pylori reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2207-2017·2017-06-07

    Cell Marque Recalls SV40 Reagent Due to Missing Export Labeling

    Cell Marque is recalling three units of SV40 (MRQ-4) reagent because they were not labeled 'For Export Only' as required by law.

    Product
    SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2168-2017·2017-06-07

    Tosoh AIA-PACK TPOAb Control Set Recalled for Labeling Errors

    Tosoh Bioscience is recalling 15 boxes of AIA-PACK TPOAb Control Sets because the labels included instructions for a non-FDA approved methodology.

    Product
    AIA-PACK TPOAb CONTROL SET
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-2199-2017·2017-06-07

    Cell Marque Recalls Adenovirus Reagents Due to Export Labeling Error

    Cell Marque is recalling Adenovirus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2214-2017·2017-06-07

    Acumedia Recalls Beef Extract Powder Due to Incorrect Expiration Date

    Acumedia Manufacturers, Inc. is recalling 16 units of Beef Extract Powder (PN 7228) because the label displays an incorrect expiration date.

    Product
    Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2167-2017·2017-06-07

    Randox Liquid Urine Control Level 3 Recalled for Labeling Error

    Randox Laboratories is recalling 198 kits of Liquid Urine Control Level 3 due to a labeling error affecting Total Protein values.

    Product
    Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2200-2017·2017-06-07

    Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling

    Cell Marque is recalling specific lots of Estrogen Receptor reagents because they were not labeled 'For Export Only' as required by law.

    Product
    Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2206-2017·2017-06-07

    Cell Marque Recalls Herpes Simplex Virus II Reagents for Labeling Errors

    Cell Marque is recalling specific lots of Herpes Simplex Virus II reagents because they were not properly labeled as 'For Export Only' as required by federal law.

    Product
    Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2213-2017·2017-06-07

    Acumedia Nutrient Gelatin Recalled for Incorrect Expiration Date Labeling

    Acumedia Manufacturers recalled 5 units of Nutrient Gelatin because the label displayed an incorrect expiration date.

    Product
    Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2250-2017·2017-05-31

    Schiff Move Free Advanced Tablets Recalled for Incorrect Packaging

    RB Manufacturing is recalling Schiff Move Free Advanced Plus MSM & Vitamin D3 tablets due to incorrect packaging.

    Product
    Schiff Move Free Advanced Plus MSM & Vitamin D3 with Glucosamine + Chondroitin, 80 Coated Tablets, Dietary Supplement, Product item number: 20525-11873
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0857-2017·2017-05-31

    Sun Pharmaceutical Recalls Children's Cetirizine Tablets for Hardness Issues

    Sun Pharmaceutical Industries is recalling 13,200 bottles of Children's Cetirizine Hydrochloride Chewable Tablets due to out-of-specification tablet hardness.

    Product
    Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2121-2017·2017-05-31

    Medtest Recalls Pointe Scientific Chemistry Controls Due to Mean Assignment Error

    Medtest Holdings is recalling Pointe Scientific Chemistry Controls Level I and II because the original mean assigned to the controls was too high, resulting in a new assigned mean outside the published range.

    Product
    Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0858-2017·2017-05-31

    Strides Pharma Recalls Benzonatate Capsules for Stability Failure

    Strides Pharma Inc. is recalling Benzonatate capsules due to out-of-specification preservative levels. The FDA classified this as a Class III recall.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0859-2017·2017-05-31

    Qualitest Recalls Hydrocortisone Lotion for Excessive Potency

    Qualitest Pharmaceuticals is recalling 109,620 bottles of Hydrocortisone Lotion, USP, 2.5% because the product is superpotent, meaning it contains more active ingredient than specified.

    Product
    HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowNHTSA·17V352000·2017-05-31

    Volkswagen Recalls 2017 Jetta for VIN Marking Mismatch

    Volkswagen is recalling 2017 Jetta vehicles because the VIN on the body does not match the VIN plate near the windshield, violating federal certification regulations.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0787-2017·2017-05-24

    Teligent Recalls Desoximetasone Ointment Due to Superpotent Drug Classification

    Teligent, Inc. is voluntarily recalling 3,600 tubes of Desoximetasone Ointment 0.25% in Tennessee due to a superpotent drug classification.

    Product
    Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2116-2017·2017-05-24

    Medtest Holdings Recalls Pointe Scientific Hitachi AST Reagent Due to Labeling Discrepancy

    Medtest Holdings is recalling Pointe Scientific Hitachi AST Reagent because the package insert contains inconsistent linearity values in different sections.

    Product
    Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2096-2017·2017-05-24

    Abbott AMO Vitrectomy Cutters Recalled for Packaging Error

    Abbott Medical Optics is recalling 360 AMO Vitrectomy Cutters because 20GA and 25GA models may be packaged in the wrong sizes.

    Product
    AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
    Category
    Medical Device
    Distribution
    0 states