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.

2576–2600 of 2769

  • LowFDA (Drugs)·D-162-2013·2013-02-20

    Ranbaxy Recalls Lac-Hydrin Lotion Due to Crystallization Texture

    Ranbaxy Inc. is recalling 4,016 bottles of Lac-Hydrin Lotion, 12%, due to a gritty texture caused by crystallization.

    Product
    Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-164-2013·2013-02-20

    West-ward Recalls Subpotent Glycopyrrolate Tablets in Ohio

    West-ward Pharmaceutical Corp. voluntarily recalled 1,185 bottles of Glycopyrrolate Tablets, USP, 1 mg, in Ohio due to subpotent drug content.

    Product
    Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Food)·F-0976-2013·2013-02-20

    Guava Mini Turnovers Recalled for Undeclared Red #40 Dye

    Suadel Food Products is recalling 3,672 units of Estrella Pastelillos de Guayaba sold in Puerto Rico due to undeclared Red #40 dye.

    Product
    "Estrella Food Products, Inc***Pastelillos de Guayaba (Guava Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0812-2013·2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-163-2013·2013-02-20

    Ranbaxy Recalls Lac-Hydrin Cream Due to Crystallization

    Ranbaxy Inc. is recalling specific lots of Lac-Hydrin (ammonium lactate) Cream, 12%, due to a gritty texture caused by crystallization.

    Product
    Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-146-2013·2013-02-13

    Ascend Recalls EstroGel Pump Defect

    Ascend Therapeutics is recalling 4,835 bottles of EstroGel (estradiol gel) 0.06% because the pump head may detach from the canister.

    Product
    EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0981-2013·2013-02-13

    NBTY Recalls Pure Protein Grape Flavored Protein Shots

    NBTY Inc. is recalling Pure Protein Grape Flavored Protein Shots due to the detection of Lactobacillus plantarum and Lactobacillus brevis, which indicates commercial spoilage.

    Product
    PURE PROTEIN PROTEIN SHOT 25g PROTEIN, GRAPE Flavor PROTEIN DRINK 2.9 fl. oz. (86 mL), Product Number 50451, Bulk Number 36753 (Vial), UPC 7 49826 50451 3 (Vial), and Product Number 50452, Bulk Number 36753 (Carton of 6), UPC 7 49826 50452 0 (Carton). --- Carefully Manufactured
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-156-2013·2013-02-13

    Bayer Recalls Leukine Sargramostim Vials Due to Impurities

    Bayer HealthCare Pharmaceuticals is recalling Leukine sargramostim vials because a confirmed out-of-specification result for impurities was found in one lot.

    Product
    Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-151-2013·2013-02-13

    Estee Lauder DayWear Moisturizer Recalled for Potential Sunscreen Instability

    Estee Lauder is recalling DayWear Sheer Tint Release moisturizer because the sunscreen ingredient may be unstable, potentially reducing its effectiveness.

    Product
    ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YO
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0970-2013·2013-02-13

    Siya Pan Gilori Recalled for High Levels of Red Dye and Metals

    Miami Growers Inc. is recalling Siya Pan Gilori because it contains high levels of Red dye 45170-Rhodamine B-Basic Violet 10 and silver leaves and other metals.

    Product
    Siya Pan Gilori Net Wt. 180g. Distributed by: Miami Growers Inc. 80 Broadway Jersey City, NJ 07306 T 201-985-9322, 201-369-1500 Visit us: www.miamigrowersinc.com UPC 0893056003800
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0792-2013·2013-02-13

    Diagnostic Hybrids RhMK Culture Media Recalled for Fungal Contamination

    Diagnostic Hybrids is recalling RhMK culture media due to fungal contamination. The affected products are used to cultivate viruses from patient specimens.

    Product
    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0744-2013·2013-02-13

    Carestream Recalls Dental Film Due to Missing Label Symbols

    Carestream Health is recalling specific lots of Kodak Insight Dental Film because the clear carton labels are missing required symbols and manufacturer information.

    Product
    KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-144-2013·2013-02-13

    Stat Rx USA Recalls Methocarbamol Tablets Due to Incorrect Expiration Date

    Stat Rx USA is recalling 3 bottles of Methocarbamol 750 mg tablets distributed in Pennsylvania because they were labeled with an incorrect expiration date.

    Product
    Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-152-2013·2013-02-13

    Sandoz Recalls Syeda Oral Contraceptives for Incorrect Tablet Imprinting

    Sandoz is recalling Syeda oral contraceptives because some tablets have the wrong ID imprint. Consumers should stop using the affected lot and contact a healthcare provider.

    Product
    Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0747-2013·2013-02-06

    Alere Cholestech LDX Calibration Verification Recall for HDL Errors

    Alere San Diego, Inc. is recalling 614 kits of Cholestech LDX Calibration Verification due to out-of-range HDL cholesterol results.

    Product
    Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0746-2013·2013-02-06

    Alere Cholestech LDX Multianalyte Control Recalled for HDL Errors

    Alere San Diego, Inc. is recalling Alere Cholestech LDX Multianalyte Control kits because they may produce out-of-range HDL cholesterol results.

    Product
    Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglyceri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0745-2013·2013-02-06

    Siemens Dimension IRON Calibrator Recalled for Calibration Slope Issues

    Siemens Healthcare Diagnostics is recalling Dimension IRON Calibrators because some lots produced calibration results outside acceptable ranges.

    Product
    Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-142-2013·2013-02-06

    Femtrace 0.45 mg Tablets Recalled for Moisture Ingress

    Warner Chilcott is recalling 3,155 bottles of Femtrace 0.45 mg tablets due to moisture ingress that failed impurity specifications.

    Product
    Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0917-2013·2013-01-30

    Coca-Cola Recalls 12-Ounce Cans Due to Off Taste and Odor Complaints

    The Coca-Cola Company is recalling 12-ounce aluminum cans in Florida due to complaints of off taste and odor.

    Product
    Coca-Cola, 12 fluid ounce aluminum cans in 20-packs and 32-packs, The Coca Cola Company.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-136-2013·2013-01-30

    Flanax Antacid Recalled for Missing Tamper-Evident Cap Band

    Belmora LLC is recalling 17,996 bottles of Flanax antacid because the caps lack a tamper-evident breakaway band.

    Product
    Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-134-2013·2013-01-30

    Major Oral Peroxide Recalled Due to Stability Data Concerns

    Axcentria Pharmaceuticals is recalling Major Oral Peroxide because stability data indicates the product degrades below acceptable levels before the printed expiration date.

    Product
    Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0683-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 670 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0677-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0679-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling specific lots of GranuFlo Dry Acid Concentrate because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0678-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 14,240 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide