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.

2276–2300 of 2769

  • LowFDA (Food)·F-1441-2014·2014-02-05

    LSG Food World Recalls Jam-Filled Bread for Missing English Label Translation

    LSG Food World Inc. is recalling Bread Filled with Jam and Bean Paste Bread because the product labels lack English translations.

    Product
    Bread Filled with Jam, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0865-2014·2014-02-05

    GE Centricity Laboratory System Software Recall for Calculation Errors

    GE Healthcare is recalling Centricity Laboratory System software due to a defect that may report calculated results as 0 or truncate them.

    Product
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1440-2014·2014-02-05

    LSG Food World Recalls Bean Paste Bread for Labeling Defect

    LSG Food World Inc. is recalling Bean Paste Bread because the product label lacks an English translation. The recall covers 1,050 cartons distributed in New York.

    Product
    Bean Paste Bread, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0821-2014·2014-01-29

    Puritan Bennett Ventilator Manual Addendum Corrected for Oxygen Sensor Life

    Nellcor Puritan Bennett is correcting a labeling error in the PB840 Operator's Manual Addendum that incorrectly stated the oxygen sensor life as two years instead of one.

    Product
    Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0789-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arterioveno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0801-2014·2014-01-29

    Philips CT Scanner Recall for Obscured Machine Name Label

    Philips is recalling 32 CT scanners because the machine name label is obscured in TumorLOC Basic Mode, preventing users from viewing or changing the name.

    Product
    Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-747-2014·2014-01-29

    Teva Recalls Fluconazole Oral Suspension for Low Preservative Content

    Teva Pharmaceuticals is recalling Fluconazole Oral Suspension because the product has preservative levels below the required specification.

    Product
    Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-739-2014·2014-01-22

    Novartis Recalls Comtrex Nighttime Cold and Cough Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Nighttime Cold & Cough because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsipp
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-738-2014·2014-01-22

    Novartis Recalls Comtrex Cold and Cough Caplets Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Cold & Cough caplets because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: No
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-741-2014·2014-01-22

    Novartis Recalls Maximum Strength Comtrex Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Severe Cold & Sinus because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, N
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-742-2014·2014-01-22

    Novartis Recalls Theraflu Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-743-2014·2014-01-22

    Novartis Recalls Theraflu Nighttime Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Nighttime Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consume
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1426-2014·2014-01-22

    Biery Cheese Co Recalls Shredded Swiss Cheese Due to Foreign Material

    Biery Cheese Co is recalling 5 lb bags of Shredded Swiss Cheese after a customer reported finding foreign yellow plastic material in the product.

    Product
    Shredded Swiss Cheese, INGREDIENTS: Milk, Cheese Culture, Enzymes......Aged 60 days. CONTAINS: MILK NET WT. 80 OZ. (5 LB.) 2.2kg MFG By Biery cheese Co., Louisville, OH 44641
    Category
    Food
    Distribution
    7 states
  • LowFDA (Drugs)·D-740-2014·2014-01-22

    Novartis Recalls Maximum Strength Comtrex Day/Night Flu Therapy

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Flu Therapy due to an unknown degradant found during stability testing.

    Product
    Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-400-2014·2014-01-15

    Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-398-2014·2014-01-15

    Mutual Pharmaceutical Recalls FIBRICOR Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling FIBRICOR (fenofibric acid) tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-399-2014·2014-01-15

    Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-391-2014·2014-01-08

    G & W Fluocinolone Acetonide Cream Recalled for Content Uniformity Failure

    G & W Laboratories is recalling Fluocinolone Acetonide Cream 0.025% because it failed content uniformity specifications at the 18-month time point.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-394-2014·2014-01-08

    Qualitest Recalls Cetirizine Hydrochloride Syrup Due to Impurity Failure

    Qualitest Pharmaceuticals is recalling 438,055 bottles of Cetirizine Hydrochloride Syrup because the product failed impurity specifications for 4-chlorobenzophenone.

    Product
    Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0619-2014·2014-01-08

    AdvanDx Gram-Negative QuickFISH BC Kits Recalled for Microscope Incompatibility

    AdvanDx is recalling Gram-Negative QuickFISH BC kits because they are incompatible with certain fluorescence microscope light sources.

    Product
    AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-0614-2014·2014-01-08

    Merit Medical Systems Recalls Maestro Microcatheters Due to Label Graphic Discrepancy

    Merit Medical Systems is recalling 59 Maestro Microcatheters because the graphic on the carton's end panel does not match the front panel.

    Product
    Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, emb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0815-2014·2014-01-08

    XYMOGEN LipiChol Medical Food Recalled for Incorrect Product Classification

    Atlantic Pro Nutrients is recalling 25,852 bottles of LipiChol and related brands because the product was labeled as a medical food instead of a dietary supplement.

    Product
    XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N2 Health, La Quinta, CA. *2. AL Metaboli
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-389-2014·2014-01-01

    Hi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures

    Hi-Tech Pharmacal is recalling Acyclovir Oral Suspension because the product's viscosity and pH levels fell below required specifications.

    Product
    Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
    Category
    Drug
    Distribution
    Distributed nationwide