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.

2501–2525 of 2769

  • LowFDA (Food)·F-1350-2013·2013-05-01

    Kwong Hung Seng Thin Soy Sauce Recalled for Insanitary Conditions

    Royal Foods, Inc. is recalling Kwong Hung Seng Thin Soy Sauce due to insanitary conditions found during a state audit, including a leaking roof and rodent activity.

    Product
    Kwong Hung Seng Sauce - Thin Soy Sauce Product is packaged in bottles Net Wt 19 Fl oz - 12 bottles per case
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-264-2013·2013-04-24

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Discoloration

    Lupin Pharmaceuticals is recalling Suprax (cefixime) oral suspension bottles because the product may not meet color specifications after reconstitution.

    Product
    Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1125-2013·2013-04-24

    Instrumentation Industries Recalls Manual Jet Ventilators for Updated Directions

    Instrumentation Industries is recalling specific manual jet ventilators and accessories to replace previously distributed Directions for Use with updated versions.

    Product
    Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet
    Category
    Medical Device
    Distribution
    44 states
  • LowFDA (Drugs)·D-248-2013·2013-04-24

    Actavis Recalls BuPROPion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

    Actavis South Atlantic LLC is recalling 555,672 bottles of buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1148-2013·2013-04-24

    Alere Recalls Mononucleosis Rapid Test Devices Due to False Negative Risk

    Alere San Diego is recalling 78 kits of the Clearview Mononucleosis Cassette because the positive control may produce false negative results.

    Product
    IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1087-2013·2013-04-17

    Lighthouse For The Blind Recalls Antiseptic Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling 2,815 antiseptic kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.

    Product
    LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1086-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling

    Lighthouse For The Blind is recalling 635 Type I First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.

    Product
    LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1088-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling

    Lighthouse For The Blind is recalling 56,133 First Aid Type I Individual Kits because the iodine ampule labels incorrectly imply the entire package is sterile.

    Product
    LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-246-2013·2013-04-17

    Teva Recalls Jolessa Tablets Due to Appearance Specification Failures

    Teva Pharmaceuticals is recalling specific lots of Jolessa tablets because they failed appearance specifications. The recall is nationwide.

    Product
    JOLESSA — JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-245-2013·2013-04-17

    Teva Recalls Portia Tablets Due to Appearance Specification Failures

    Teva Pharmaceuticals is recalling Portia (levonorgestrel and ethinyl estradiol) tablets because they failed appearance specifications.

    Product
    PORTIA — PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1075-2013·2013-04-17

    Tosoh G7 HPLC Analyzer Recalled for Beta-Thalassemia Detection Failure

    Tosoh Bioscience Inc is recalling G7 HPLC analyzers because the Beta-thalassemia mode failed to detect the A2 peak in whole blood samples.

    Product
    G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1090-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling 41,595 First Aid Type III kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.

    Product
    LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1092-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling First Aid Type IV Belt Type kits because the iodine ampule labels incorrectly imply the entire package is sterile.

    Product
    LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1091-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling

    Lighthouse For The Blind is recalling 227 First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.

    Product
    LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1089-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling 1,034 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.

    Product
    LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1093-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits With Misleading Sterility Labels

    Lighthouse For The Blind is recalling 425 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.

    Product
    LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1304-2013·2013-04-17

    Ferrous Sulfate Tablets Recalled for Foreign Material Contamination

    Magno Humphries Inc is recalling Ferrous Sulfate Tablets 325 mg due to the presence of minute pieces of blue polypropylene plastic.

    Product
    Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. Label reads in part "OPTIMUM *** FERROUS SULFATE 325 * mg 5 Grain *** Gluten Free Dietary Supplement *** Manufactured & Distributed by: Magno-Humphries Labs Tigard, OR 97223 U.S.A. *** *325 mg calculat
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1047-2013·2013-04-10

    Siemens Dimension EXL LM STM Recalled for System Check Failures

    Siemens is recalling 2,207 Dimension EXL LM STM analyzers worldwide due to System Check failures that cause inconvenience but do not affect test results.

    Product
    Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-238-2013·2013-04-10

    Dr. Reddy's Recalls Tizanidine Tablets Due to Illegible Labeling

    Dr. Reddy's Laboratories is recalling Tizanidine Tablets because bottle labels may be missing the product strength and other printing details.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1284-2013·2013-04-10

    TJX Recalls Mrs. Bridges Scottish Raspberry Preserve Due to Contaminants

    The TJX Companies is recalling Mrs. Bridges Scottish Raspberry Preserve due to the discovery of contaminants. The product was distributed nationwide in 12 states and Puerto Rico.

    Product
    Mrs. Bridges Scottish Raspberry Preserve ("Jam"); Net Wt. 42g /1.5oz; service size 15g; servings per package: 2.8; ID 3779300377 Manufactured for: Kimm & Miller (UK) Ltd. mille Road, Bedford, MK429TW. United Kingdom; Manufacturer: Mackays Ltd., James Chalmers Road, Kirkton Ind E
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1048-2013·2013-04-10

    Siemens Dimension EXL 200 Recalled for System Check Failures

    Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL 200 analyzers worldwide due to increased System Check failures that cause inconvenience but do not impact test results.

    Product
    Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-241-2013·2013-04-10

    Fougera Recalls Ketoconazole Cream 2% Due to Unknown Degradant

    Fougera Pharmaceuticals is voluntarily recalling 60,210 units of Ketoconazole Cream 2% because an unknown degradant failed impurity specifications.

    Product
    KETOCONAZOLE — KETOCONAZOLE (KETOCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1046-2013·2013-04-10

    Siemens Dimension EXL LM Analyzer Recalled for System Check Failures

    Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL LM analyzers worldwide due to increased System Check failures that cause inconvenience but do not affect test results.

    Product
    Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1025-2013·2013-04-10

    Viscot Medical Recalls Dual Tip Markers Due to Inconsistent Ink Flow

    Viscot Medical LLC is recalling 458,589 sterile dual tip markers because the black permanent ink side has inconsistent ink flow.

    Product
    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1007-2013·2013-04-03

    Cooper Surgical Incontinence Dish Folding Pessary Mislabeled Size Recall

    Cooper Surgical is recalling Incontinence Dish Folding Pessaries because the outer package may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide