The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

13326–13350 of 21617

  • ModerateFDA (Food)·F-0932-2017·2017-01-04

    Sunset Natural Products Recalls Liver Energy Dietary Supplement

    Sunset Natural Products Inc. is recalling Liver Energy dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Liver Energy, 100 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0930-2017·2017-01-04

    Sterling Diagnostics Recalls HDL Cholesterol Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling HDL Cholesterol diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0875-2017·2017-01-04

    Neusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error

    Neusoft Medical Systems is recalling 23 NeuViz 64 CT scanners because a software error may interrupt scans, requiring a system restart to resume.

    Product
    NeuViz 64 Multi-slice CT Scanner Systems
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0234-2017·2017-01-04

    Raritan Recalls CVS Kids' Ear Relief Liquid for Manufacturing Deviations

    Raritan Pharmaceuticals is voluntarily recalling 20,448 bottles of CVS pharmacy Kids' Ear Relief Oral Liquid due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0876-2017·2017-01-04

    NeuViz 128 CT Scanner Software Recall for Scan Interruption Errors

    Neusoft Medical Systems is recalling 23 NeuViz 128 CT scanners due to software errors that interrupt scans during contrast agent tracking.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0961-2017·2017-01-04

    Sunset Natural Products Recalls Prostaliv New Dietary Supplement

    Sunset Natural Products Inc. is recalling Prostaliv New dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Prostaliv New, 60 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0934-2017·2017-01-04

    Sunset Natural Products Recalls Hepasil Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling 2,650,000 capsules of Hepasil pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    Hepasil, (various bulk amounts)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0956-2017·2017-01-04

    Sunset Natural Products Recalls Weight 2.0 Dietary Supplement

    Sunset Natural Products Inc. is recalling Weight 2.0 dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Weight 2.0, 120 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0233-2017·2017-01-04

    Raritan Recalls Kids' Relief Ear Liquid Due to Manufacturing Deviations

    Raritan Pharmaceuticals is recalling 22,704 bottles of Kids' Relief Ear Relief Oral Liquid in New York due to CGMP deviations.

    Product
    Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0906-2017·2017-01-04

    Bio-Botanica Recalls Vitamin D-3 Drops for Excess Dosage

    Bio-Botanica is recalling Nature's Answer and Seeking Health Vitamin D-3 drops because the lots contain more Vitamin D3 than the label claims.

    Product
    Liquid VITAMIN D-3 Drops distributed under the following private labels and sizes: a) NATURE'S ANSWER VITAMIN D-3 DROPS DIETARY SUPPLEMENT, 0.5 FLUID OZ/15 mL, UPC 8300026132 -- Nature's Answer Hauppauge, NY 11788; and b) Seeking Health Optimal Vitamin D, Liquid Vitamin D-3…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2017·2017-01-04

    Sandoz Recalls Nadolol Tablets Due to Failed Dissolution Test

    Sandoz Incorporated is recalling 96 bottles of Nadolol Tablets, 40mg, because the product failed a required dissolution test.

    Product
    Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0232-2017·2017-01-04

    CVS Health Homeopathic Infants Teething Tablets Recalled for CGMP Deviations

    Raritan Pharmaceuticals is voluntarily recalling CVS Health Homeopathic Infants Teething Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0958-2017·2017-01-04

    Sunset Natural Products Recalls Chardon De Marie Dietary Supplement

    Sunset Natural Products Inc. is recalling Chardon De Marie capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    Chardon De Marie, 60 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1056-2017·2017-01-04

    Sunset Natural Products Recalls Denta Capsule Dietary Supplement

    Sunset Natural Products Inc. is recalling Denta capsule dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.

    Product
    Denta capsule Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0937-2017·2017-01-04

    Sunset Natural Products Recalls Prostax Forte Dietary Supplement

    Sunset Natural Products Inc. is recalling Prostax Forte dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Prostax Forte, (50,000 capsule bulk)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0240-2017·2017-01-04

    Virtus Pharmaceuticals Recalls Virt-Select Prenatal Softgels Due to GMP Deviations

    Virtus Pharmaceuticals is recalling Virt-Select Prenatal/Postnatal Softgels because the active ingredient manufacturer is on an FDA Import Alert for cGMP deviations.

    Product
    Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1059-2017·2017-01-04

    Sunset Natural Products Recalls Libene Dietary Supplement Under Consent Decree

    Sunset Natural Products Inc. is recalling Libene Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.

    Product
    Libene Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0903-2017·2017-01-04

    Ortho-Clinical Diagnostics Recalls VITROS Intact PTH Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to a positive bias of up to 20% and an incorrectly set reference interval.

    Product
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma…
    Category
    Medical Device
    Distribution
    Distributed nationwide