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.

1251–1275 of 2741

  • LowFDA (Drugs)·D-0928-2017·2017-07-05

    BuPROPion HCL Tablets Recalled for Moisture Content Failures

    Mckesson Packaging Services is recalling BuPROPion HCL Tablets, 75 mg, due to out-of-specification moisture content.

    Product
    BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2650-2017·2017-07-05

    Medtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch

    Medtest Holdings is recalling Pointe Scientific Liquid Creatine Kinase Reagent Sets because the product insert does not match the approved premarket notification.

    Product
    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0925-2017·2017-07-05

    L. Perrigo Recalls Walgreens Cold and Flu Combo Packs Due to Label Error

    L. Perrigo is recalling 1,998 Walgreens Daytime and Nighttime Cold & Flu combo packs in Illinois because the packaging sleeve incorrectly identifies the contents as Day-Night Cold and Flu instead of Day-Night Cough Liquid.

    Product
    Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2631-2017·2017-07-05

    Medtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling

    Medtest Holdings is recalling Pointe Scientific CRP calibrator and standard sets because vial labels incorrectly list units as mg/dl instead of mg/L.

    Product
    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the…
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2649-2017·2017-07-05

    Medtest Holdings Recalls CK-MB Control Kits Due to Labeling Error

    Medtest Holdings is recalling five CK-MB Isoenzyme Control Kits because the product labeling contains an incorrect control range.

    Product
    The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-0910-2017·2017-06-21

    Pharmedium Recalls IV Bags With Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 912 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0913-2017·2017-06-21

    Pharmedium Recalls IV Bags with Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 216 bags of Potassium Phosphate in 0.9% Sodium Chloride because the total volume was incorrectly printed on the label.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0906-2017·2017-06-21

    Pharmedium Recalls 216 Bags of Potassium Chloride with Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride in 0.9% Sodium Chloride because the product labels incorrectly state a volume of 115.00 mL instead of the actual 100.00 mL.

    Product
    Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2587-2017·2017-06-21

    Teleflex Recalls Sheridan Intubating Stylets Due to Incorrect Size Labeling

    Teleflex Medical is recalling Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets because the product size listed on the labeling is incorrect.

    Product
    Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0909-2017·2017-06-21

    Pharmedium Recalls IV Bags With Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 192 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0912-2017·2017-06-21

    Pharmedium Recalls Potassium Phosphate IV Bags Due to Labeling Error

    Pharmedium Services is recalling 48 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0920-2017·2017-06-21

    Mylan Recalls Montelukast Sodium Oral Granules Due to Impurity Failures

    Mylan Pharmaceuticals is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, due to failed impurity specifications.

    Product
    Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2539-2017·2017-06-21

    Cook Multi-Use Holmium Laser Fibers Recalled for Reprocessing Instruction Deficiencies

    Cook Inc. is recalling 4,369 multi-use holmium laser fibers because the current instructions for use do not provide sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Drugs)·D-0907-2017·2017-06-21

    Pharmedium Recalls Potassium Chloride Bags With Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 143 bags of Potassium Chloride in 0.9% Sodium Chloride because the product label incorrectly states the total volume as 105.00 mL instead of 100.00 mL.

    Product
    Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0911-2017·2017-06-21

    Pharmedium Recalls Potassium Phosphate IV Bags Due to Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 672 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowNHTSA·17V387000·2017-06-20

    KZRV Recalls 2018 Recreational Trailers Due to Missing Certification Date

    KZRV is recalling 2018 recreational trailers because the Federal Certification label lacks the manufacturing date, potentially preventing owners from identifying other safety recalls.

    Product
    KZRV — KZRV VENOM, SPORTSMEN SPORTSTER, SPREE, SPORT TREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2309-2017·2017-06-14

    Beekley Medical Mammography Skin Markers Recalled for Mislabeling

    Beekley Corporation is recalling 0-SPOT Mammography Skin Markers because they were mislabeled with A-SPOT labels. The recall affects 6,032 units distributed in the US and Canada.

    Product
    Beekley Medical 0-SPOT Mammography Skin Markers REF 652
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2252-2017·2017-06-14

    Argon Medical Recalls Arterial Access Needles Due to Packaging Defect

    Argon Medical Devices is recalling specific arterial access needles due to a potential packaging defect involving unsealed pouches.

    Product
    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2316-2017·2017-06-14

    MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values

    Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.

    Product
    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0897-2017·2017-06-14

    Hetero USA Recalls Acyclovir Tablets Due to Human Hair Presence

    Hetero USA Inc. is recalling 13,692 bottles of Acyclovir 800 mg tablets because human hair was found melded into the tablets.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2221-2017·2017-06-14

    Acumedia Urea Base Agar Recalled for Incorrect Storage Labeling

    Acumedia is recalling Urea Base Agar because the label listed an incorrect storage temperature range.

    Product
    Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2210-2017·2017-06-07

    Cell Marque Recalls HHV-8 Reagent Due to Export Labeling Error

    Cell Marque is recalling HHV-8 in vitro diagnostic reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide