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.

801–825 of 2738

  • LowFDA (Drugs)·D-1067-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

    Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurities were detected at the 24-month time point.

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1058-2019·2019-04-03

    Ingenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles

    Ingenus Pharmaceuticals is recalling 29,435 bottles of Diclofenac Sodium Topical Solution because some bottles were found leaking.

    Product
    Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1073-2019·2019-04-03

    CryoLife Recalls Two On-X Aortic Heart Valves for Mislabeled Serial Numbers

    CryoLife, Inc. is recalling two On-X Aortic Heart Valves because they were mislabeled with incorrect serial numbers. The devices were distributed in Georgia and Germany.

    Product
    On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1188-2019·2019-04-03

    Jimmy's Original Blue Cheese Salad Dressing Recalled for Labeling Error

    Fish House Dressing is recalling 1,741 jars of Jimmy's Original Blue Cheese Salad Dressing because the product may be mislabeled as French Blue Cheese.

    Product
    Jimmy's Original Blue Cheese Salad Dressing 15 Fl. Oz (443 ml). UPC 86824-22345 Keep Refrigerated. Manufactured by: Fish House Dressing, 1171 2nd Ave NE, Stewartville, MN 55976
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-1024-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1034-2019·2019-03-27

    Agfa Radiographic Film Recalled for Visible Pinholes in Images

    Agfa N.V. is recalling specific lots of PET Plates Coated Film-MONOMEDBV2S2 radiographic film because inhomogeneous coating solutions cause visible pinholes in images.

    Product
    PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1026-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1023-2019·2019-03-27

    Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates

    Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.

    Product
    Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1025-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filters to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1022-2019·2019-03-27

    Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates

    Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.

    Product
    Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1021-2019·2019-03-27

    Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates

    Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use.

    Product
    Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0991-2019·2019-03-20

    Boehringer Ingelheim Recalls Mirapex Tablets Due to Low Weight

    Boehringer Ingelheim is recalling 112 cartons of Mirapex 1 mg tablets because routine stability testing identified low-weight tablets.

    Product
    Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0994-2019·2019-03-13

    Petra Hygienic Systems Recalls Athleticare Hand Soap Due to Triclosan

    Petra Hygienic Systems is recalling Athleticare Anti-Bacterial Hand Soap because it contains triclosan, an ingredient no longer permitted in over-the-counter antiseptic wash products.

    Product
    ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0519-2019·2019-03-13

    Jubilant Cadista Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications at a 9-month stability timepoint.

    Product
    BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0517-2019·2019-03-06

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Impurity Levels

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because impurity levels exceeded specifications. The recall covers 674,628 bottles distributed nationwide and in Puerto Rico.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0958-2019·2019-03-06

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Packaging Instructions

    Exactech is recalling 40 Equinoxe Preserve Humeral Stems because they may have been packaged with instructions for a different knee implant.

    Product
    Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1099-2019·2019-03-06

    Prolacta Bioscience Recalls Unreleased Human Milk Caloric Fortifier Lot

    Prolacta Bioscience is recalling a specific lot of human milk caloric fortifier that was under quarantine and not released for distribution.

    Product
    Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, Net 40 mL (1.2 fl.oz. Intended for premature/LBW Infants fed human milk. Ingredients: Human milk cream and human milk ultrafiltration permeate.…
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0512-2019·2019-02-27

    Perrigo Recalls Ciclopirox Shampoo Due to Stability Testing Failures

    Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.

    Product
    CICLOPIROX — CICLOPIROX (CICLOPIROX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0506-2019·2019-02-27

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0497-2019·2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotent Drug Concerns

    Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0514-2019·2019-02-27

    Mometasone Furoate Cream Recalled for NDC Typographical Error

    ACP Nimble Buyer, Inc. is recalling Mometasone Furoate Cream due to a typographical error in the National Drug Code (NDC) on the label.

    Product
    Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2019·2019-02-27

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
    Category
    Drug
    Distribution
    0 states