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.

851–875 of 2769

  • LowFDA (Devices)·Z-0516-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0508-2019·2018-12-05

    WOM World of Medicine Recalls PNEUMOCLEAR Heated High-Flow Tube Sets

    WOM World of Medicine AG is recalling PNEUMOCLEAR Heated High-Flow Tube Sets because packaging may be damaged by the tube set prongs.

    Product
    PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnost
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-0671-2019·2018-12-05

    Red Bull Energy Drink Recalled for Excess Ingredient Levels

    Red Bull North America Inc. is recalling specific batches of 8.4 fl. oz. Red Bull Energy Drink because they contain three times the specified level of primary ingredients.

    Product
    Red Bull Energy Drink, 8.4 Fl. oz. (250 mL) Ingredient: Carbonated water, Sucrose, Glucose, Citric Acid, Taurine, Sodium Bicarbonate, Magnesium, Carbonate Caffeine, Nicainamide, Calcium Pantothenate, Pyridoxine HCL, Vitamin B12, Natural and artificial Flavors, colors. UPC
    Category
    Food
    Distribution
    5 states
  • LowFDA (Drugs)·D-0284-2019·2018-12-05

    RemedyRepack Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    RemedyRepack Inc. is recalling specific lots of Nitrofurantoin Monohydrate/Macrocrystals capsules due to potential cross-contamination with unrelated ingredients.

    Product
    Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard tra
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0262-2019·2018-11-21

    Sandoz Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    Sandoz Inc. is recalling specific lots of Nitrofurantoin Capsules 100 mg due to cross-contamination with other products.

    Product
    Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0425-2019·2018-11-21

    Kroger Recalls Simple Truth Organic Red Quinoa for Pesticide Non-Compliance

    The Kroger Co is recalling Simple Truth Organic Red Quinoa because the product was not in compliance for pesticide exclusion.

    Product
    simple truth organic Red Quinoa Ingredients: organic red quinoa Distributed by The Kroger Co, Cincinnati, OH UPC1111086333 NET WT 16 oz (1 lb)
    Category
    Food
    Distribution
    7 states
  • LowFDA (Drugs)·D-0286-2019·2018-11-21

    Takeda Recalls Amitiza Capsules Due to Elevated Impurity Levels

    Takeda is recalling specific lots of Amitiza (lubiprostone) capsules because stability testing found elevated levels of a known impurity.

    Product
    AMITIZA — AMITIZA (LUBIPROSTONE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0279-2019·2018-11-21

    Breckenridge Recalls Megestrol Acetate Oral Suspension for Stability Failures

    Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension due to out-of-specification particle size results during stability testing.

    Product
    Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0240-2019·2018-11-21

    Right Value Drug Stores Recalls Progesterone SR 100 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling 6,580 capsules of Progesterone SR 100 mg due to misbranding. The affected product was distributed in California.

    Product
    Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0414-2019·2018-11-21

    Collagen Matrix Recalls BioMend Extend Due to Potential Packaging Error

    Collagen Matrix, Inc. is recalling 569 units of BioMend Extend synthetic bone grafting material because the product may have been packaged in the wrong box.

    Product
    BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0243-2019·2018-11-21

    Right Value Drug Stores Recalls Tadalafil SR 12 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling Tadalafil SR 12 mg capsules distributed in California due to labeling misbranding.

    Product
    Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376 NDC 99999-9969-51
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0241-2019·2018-11-21

    Right Value Drug Stores Recalls Progesterone SR 200 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling specific lots of Progesterone SR 200 mg Capsules due to misbranding. The affected products were distributed in California.

    Product
    Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0018-74
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0242-2019·2018-11-21

    Right Value Drug Stores Recalls Tadalafil SR 7 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling Tadalafil SR 7 mg capsules due to misbranding. The affected lots were distributed in California.

    Product
    Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0245-2019·2018-11-21

    RemedyRepack Recalls Metoprolol Tartrate Injection Due to pH Failures

    RemedyRepack Inc. is recalling specific lots of Metoprolol Tartrate Injection because stability testing showed high pH levels that failed specifications.

    Product
    Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0389-2019·2018-11-14

    Medtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels

    Medtest Holdings is recalling 22 vials of AutoHDL/LDL Cholesterol Calibrator shipped without labels in five states.

    Product
    Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0410-2019·2018-11-14

    R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error

    R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.

    Product
    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-0219-2019·2018-11-14

    Orexigen Recalls Contrave Tablets Due to Container Packaging Defect

    Orexigen Therapeutics is recalling 18,895 bottles of Contrave extended-release tablets due to a container packaging defect. The affected lot is ZYCY with an expiration date of 04/11/2021.

    Product
    CONTRAVE — CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0323-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0349-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0329-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0283-2019·2018-11-07

    Acumedia Palcam Agar Base Recalled for Incorrect Expiration Date Labeling

    Acumedia Manufacturers, Inc. is recalling 22 bottles of Palcam Agar Base because the expiration date on the label is incorrect.

    Product
    Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0284-2019·2018-11-07

    Acumedia Campylobacter Medium Recalled for Incorrect Expiration Date

    Acumedia Manufacturers is recalling 93 bottles of Campylobacter Blood Free Selective Medium due to incorrect expiration dates.

    Product
    Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0350-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide