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.

1476–1500 of 2769

  • LowFDA (Drugs)·D-0151-2017·2016-11-30

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules because of out-of-specification results for a known compound.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0639-2017·2016-11-30

    Synthes Recalls 3.0 mm Reaming Rods Due to Pouch Delamination

    Synthes (USA) Products LLC is recalling 5,478 sterile 3.0 mm reaming rods because their peel pouches are delaminating.

    Product
    3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0147-2017·2016-11-30

    West-Ward Recalls Amoxicillin Suspension Due to Missing Strength Label Panel

    West-Ward Pharmaceuticals is recalling 32,102 bottles of Amoxicillin oral suspension because some bottles are missing the color-coded panel that displays the product strength.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0145-2017·2016-11-30

    Sandoz Recalls Ceftriaxone Sodium Vials Due to Missing Labels

    Sandoz Inc is recalling 139,430 vials of Ceftriaxone Sodium for Injection in Wisconsin due to missing labels.

    Product
    CEFTRIAXONE SODIUM — CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0148-2017·2016-11-30

    Sun Pharmaceutical Recalls KENALOG Spray Due to Low Alcohol Content

    Sun Pharmaceutical Industries is recalling KENALOG (Triamcinolone Acetonide) Spray due to low alcohol content. The product failed stability specifications.

    Product
    KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0637-2017·2016-11-30

    Synthes Recalls 2.5 mm Reaming Rods Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 1,951 sterile 2.5 mm reaming rods because their peel pouches are delaminating.

    Product
    2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0402-2017·2016-11-23

    Siemens Recalls Dimension IRON Flex Reagent Cartridges Due to Interference

    Siemens Healthcare Diagnostics is recalling Dimension IRON Flex reagent cartridges because deferoxamine interferes with the assay at a different concentration than listed in the instructions.

    Product
    Dimension IRON Flex reagent cartridges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0598-2017·2016-11-23

    Philips IQon Spectral CT System Recalled for Incorrect Label Rating

    Philips Medical Systems is recalling three IQon Spectral CT systems because the product labels do not include the correct current rating.

    Product
    IQon Spectral CT Computed Tomography X-ray system, Model 728332
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0594-2017·2016-11-23

    Philips Brilliance CT System Recalled for Incorrect Label Rating

    Philips is recalling three Brilliance ICT SP CT systems because the product labels do not include the correct current rating.

    Product
    Brilliance ICT SP Computed Tomography X-ray system, Model 728311
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Drugs)·D-0138-2017·2016-11-23

    CutisPharma Recalls Omeprazole Kits Due to Labeling Error

    CutisPharma is recalling 8,748 Omeprazole compounding kits because the package insert incorrectly lists the strength as 3mg/mL instead of 2mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0142-2017·2016-11-23

    GSK Recalls Zeasorb AF Antifungal Cream Due to Labeling Errors

    GSK Consumer Healthcare is recalling Zeasorb AF antifungal cream because some bottles have incorrect NDC codes or indications on the labels.

    Product
    Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0597-2017·2016-11-23

    Philips CT System Recalled for Incorrect Label Rating

    Philips is recalling two Ingenuity Core CT systems because the product labels do not include the correct current rating.

    Product
    Ingenuity Core Computed Tomography X-ray system, Model 728321
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0593-2017·2016-11-23

    Philips Brilliance iCT Computed Tomography System Recalled for Labeling Error

    Philips Medical Systems is recalling 67 Brilliance iCT Computed Tomography X-ray systems because the product labels do not include the correct current rating.

    Product
    Brilliance iCT Computed Tomography X-ray system, Model 728306
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Food)·F-0475-2017·2016-11-23

    Panera Bread Broccoli Cheddar Soup Recalled for Foreign Object Presence

    Blount Fine Foods is recalling Panera Bread Broccoli Cheddar Soup due to the presence of a foreign object. The product was distributed in eight states.

    Product
    Panera Bread Broccoli Cheddar Soup, 48 oz. sleeve (2/24 oz. cups/sleeve). Refrigerated UPC Code: 077958790918
    Category
    Food
    Distribution
    8 states
  • LowFDA (Devices)·Z-0595-2017·2016-11-23

    Philips Ingenuity CT System Recalled for Incorrect Label Rating

    Philips is recalling 27 Ingenuity CT systems because the product labels do not include the correct current rating.

    Product
    Ingenuity CT Computed Tomography X-ray system, Model 728326
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0596-2017·2016-11-23

    Philips CT Scanner Recall for Incorrect Product Label Rating

    Philips is recalling 15 Ingenuity Core 128 CT scanners because the product labels do not include the correct current rating.

    Product
    Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0401-2017·2016-11-23

    Siemens Recalls Dimension Vista IRON Flex Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling Dimension Vista IRON Flex reagent cartridges due to deferoxamine interference at concentrations not listed in the Instructions for Use.

    Product
    Dimension Vista IRON Flex reagent cartridges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0139-2017·2016-11-23

    CutisPharma Recalls Omeprazole Compounding Kits Due to Labeling Error

    CutisPharma is recalling 5,904 kits of FIRST Omeprazole 2mg/mL because the package insert incorrectly lists the strength as 3mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0610-2017·2016-11-23

    OMNIBotics Tracker Kit Recalled for Incorrect Lot Number Labeling

    OMNI Life Science is recalling 15 OMNIBotics Tracker Kits due to incorrect lot numbers on the outer packaging.

    Product
    OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Drugs)·D-0134-2017·2016-11-16

    Taro Recalls Kamedis Dandruff Care Kits Due to Low Active Ingredient

    Taro Pharmaceuticals is recalling 17,100 kits of Kamedis Bio-Herbal Dandruff Care System because the active ingredient, zinc pyrithione, was found to be subpotent.

    Product
    Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Bot
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0135-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling specific lots of Clonazepam Tablets, USP, 0.5 mg because they failed impurity specifications.

    Product
    Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0324-2017·2016-11-16

    Tasty Toppings Recalls Dorothy Lynch Homestyle Condiment Bottles

    Tasty Toppings Inc is recalling Dorothy Lynch Homestyle condiment bottles due to a Class III FDA recall. Consumers should return affected products to the store for a refund.

    Product
    Dorothy Lynch Homestyle 8 oz., 16 oz., and 32 oz. bottles (12/case) and 128 oz. bottles (4/case)
    Category
    Food
    Distribution
    12 states
  • LowFDA (Devices)·Z-0328-2017·2016-11-16

    SentreHeart Recalls FindrWIRZ Guidewire Systems Due to Coating Defects

    SentreHeart Inc is recalling FindrWIRZ Guidewire Systems because the lubricious coating delaminated and flaked off three units in Germany.

    Product
    FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Drugs)·D-0136-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional is recalling specific lots of Clonazepam 1.0 mg tablets because a known impurity exceeded specification limits during stability testing.

    Product
    Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
    Category
    Drug
    Distribution
    Distributed nationwide