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.

1501–1525 of 2769

  • LowFDA (Drugs)·D-0122-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1.5/30 tablets because they may contain subpotent levels of ethinyl estradiol.

    Product
    Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0121-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1/20 tablets because the ethinyl estradiol component is subpotent. The recall covers 822,009 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHAR
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0118-2017·2016-11-09

    Actavis Recalls Ramipril Capsules Due to Incorrect Expiration Date Labeling

    Actavis is recalling 15,984 bottles of Ramipril Capsules because they were labeled with an incorrect expiration date of 03/18 instead of 09/17.

    Product
    Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0115-2017·2016-11-02

    Invokamet Recalled for Incorrect or Missing Package Insert Labeling

    Janssen Ortho L.L.C. is recalling Invokamet tablets because Xarelto prescribing information outserts may be affixed to the bottles instead of the correct Invokamet inserts.

    Product
    INVOKAMET — INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0313-2017·2016-11-02

    Ortho-Clinical Diagnostics Recalls VITROS HBsAg Controls Due to Performance Drift

    Ortho-Clinical Diagnostics is recalling VITROS HBsAg Controls because signal/cutoff results may increase during the 5-day reconstituted timeframe, potentially affecting performance monitoring.

    Product
    VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0311-2017·2016-11-02

    Becton Dickinson Recalls PhoenixSpec Calibrator Kits Due to Labeling Error

    Becton Dickinson is recalling specific lots of BBL PhoenixSpec Calibrator kits because the kits are labeled with an incorrect expiration year, although the individual tubes have correct dates.

    Product
    PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-0312-2017·2016-11-02

    Becton Dickinson Recalls PhoenixSpec AP Calibrator Due to Labeling Error

    Becton Dickinson is recalling 94 units of PhoenixSpec AP Calibrator because the expiration date year is incorrectly labeled on the kit.

    Product
    PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Food)·F-0088-2017·2016-10-26

    Triceutical Recalls Premium Protein III Supplement for Manufacturing Deficiencies

    Triceutical Inc. is recalling Premium Protein III for kids due to a lack of good manufacturing practices. The recall covers 693 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    PREMIUM PROTEIN III For kids Nutritional Supplement, NET WT 16 OZ (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219. Made in USA
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0095-2017·2016-10-26

    Triceutical Recalls Joint Lubrica Rebuilds Dietary Supplements for Manufacturing Issues

    Triceutical Inc. is recalling Joint Lubrica Rebuilds dietary supplements due to a lack of good manufacturing practices. The product was distributed in Florida, New York, Pennsylvania, and China.

    Product
    Joint Lubrica Rebuilds, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305. Made in USA.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-0111-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling specific lots of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0113-2017·2016-10-26

    Osteogenics Recalls Cytoplast Membrane Due to Packaging Error

    Osteogenics Biomedical, Inc. is recalling 32 boxes of Cytoplast Titanium-Reinforced Posterior Singles Membrane because the device may be packaged in the wrong product box.

    Product
    Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0090-2017·2016-10-26

    Triceutical Recalls Hyaluronic Acid Supplements Due to Manufacturing Deficiencies

    Triceutical Inc. is recalling all lots of Byron J. Richards Hyaluronic Acid dietary supplements due to a lack of good manufacturing practices.

    Product
    Byron J. Richards Wellness resources Hyaluronic Acid Dietary Supplement, 60 Capsules, Distributed by Wellness Resources, Inc. 7155 Amundson Avenue, Minneapolis, MN 55439 800-717-WELL.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-0110-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,556 bottles of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0109-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 32,015 bottles of Paricalcitol Capsules, 1 mcg, because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0094-2017·2016-10-26

    Triceutical Recalls Joint Optima Dietary Supplements for Manufacturing Violations

    Triceutical Inc. is recalling Joint Optima dietary supplements because they were not produced under good manufacturing practices. The recall covers 1,500 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Joint Optima Rebuilds, Lubricates and Soothes Joints, Triple Strength, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305. Made in USA.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0097-2017·2016-10-26

    Triceutical Recalls Super Lecithin Complex Soft Gels for Manufacturing Issues

    Triceutical Inc. is recalling Super Lecithin Complex soft gels due to a lack of good manufacturing practices. The recall covers 1,450 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Super Lecithin Complex soft gels
    Category
    Food
    Distribution
    3 states