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.

8301–8325 of 21595

  • ModerateFDA (Drugs)·D-1631-2019·2019-08-14

    CVS Children's Allergy Relief Liquid Medication Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to potential contamination with B. cepacia bacteria. The recall is a precautionary measure.

    Product
    CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsock
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1620-2019·2019-08-14

    Herbal Doctor Remedies Recalls Worm Off Capsules Due to Manufacturing Deviations

    Herbal Doctor Remedies is recalling Worm Off 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.

    Product
    Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1602-2019·2019-08-14

    Herbal Doctor Remedies Recalls Herpes-S Capsules Due to Manufacturing Deviations

    Herbal Doctor Remedies is recalling Herpes-S 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices.

    Product
    Herpes-S, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1604-2019·2019-08-14

    Herbal Doctor Remedies Recalls Lipidtrol Capsules for Manufacturing Violations

    Herbal Doctor Remedies is recalling Lipidtrol Capsules because they were manufactured outside of current Good Manufacturing Practices controls.

    Product
    Lipidtrol Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2019·2019-08-14

    Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1615-2019·2019-08-14

    Herbal Doctor Remedies Recalls Sperm Booster for Manufacturing Violations

    Herbal Doctor Remedies is recalling Sperm Booster because it was manufactured outside of required Good Manufacturing Practice controls.

    Product
    Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1626-2019·2019-08-14

    Herbal Doctor Remedies Recalls Appetrol Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Appetrol Capsules because they were manufactured outside of current Good Manufacturing Practice controls.

    Product
    Appetrol Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1591-2019·2019-08-14

    Herbal Doctor Remedies Recalls Bone Fixer Due to Manufacturing Deviations

    Herbal Doctor Remedies is recalling Bone Fixer because it was manufactured outside of required Good Manufacturing Practices controls.

    Product
    Bone Fixer, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2177-2019·2019-08-14

    Ortho VITROS 350 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 350 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1608-2019·2019-08-14

    Herbal Doctor Remedies Recalls Lung Saver Capsules for Manufacturing Violations

    Herbal Doctor Remedies is recalling Lung Saver Capsules because they were manufactured outside of current Good Manufacturing Practices controls.

    Product
    Lung Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2019·2019-08-14

    Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2019·2019-08-14

    Philips Recalls Vereos PET/CT Systems Due to Image Labeling Error

    Philips is recalling 26 Vereos PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    Vereos PET/CT Model # 882446, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2019·2019-08-14

    Randox Human Assayed Multi-Sera Level 2 Recalled for Incorrect Control Values

    Randox Laboratories is recalling Human Assayed Multi-Sera Level 2 controls due to incorrectly assigned target and range values for specific analytes.

    Product
    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2174-2019·2019-08-14

    Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 250 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2160-2019·2019-08-14

    Howmedica Serrato Polyaxial Screws Recalled for Incorrect Length

    Howmedica Osteonics Corp. is recalling 11 Serrato polyaxial screws because some 90mm and 100mm units were manufactured with the wrong length.

    Product
    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2217-2019·2019-08-14

    MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error

    Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.

    Product
    14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2181-2019·2019-08-14

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 825 VITROS 4600 Chemistry Systems worldwide due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 4600 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1595-2019·2019-08-14

    Dragon Pain Oil Recalled for Manufacturing Process Deviations

    Herbal Doctor Remedies is recalling Dragon Pain Oil because it was manufactured outside of required Good Manufacturing Practices controls.

    Product
    Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1632-2019·2019-08-14

    Unipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk

    Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1601-2019·2019-08-14

    Herbal Doctor Remedies Recalls Herpes-P Capsules for Manufacturing Deviations

    Herbal Doctor Remedies is recalling Herpes-P 500 mg capsules because they were manufactured outside of current Good Manufacturing Practices controls.

    Product
    Herpes-P, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2019·2019-08-14

    Centurion Driveline Management System 1 Daily Kit Recalled for Packaging Risk

    Centurion Medical Products is recalling 6,180 Driveline Management System 1 Daily Kits because sterile packaging may be compromised.

    Product
    DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2175-2019·2019-08-14

    Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 250 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1597-2019·2019-08-14

    Herbal Doctor Remedies Recalls Fungo Balm Due to Manufacturing Deviations

    Herbal Doctor Remedies is recalling Fungo Balm because it was manufactured outside of required Good Manufacturing Practices controls.

    Product
    Fungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1614-2019·2019-08-14

    Herbal Doctor Remedies Recalls Psoriasis Balm Due to Manufacturing Deviations

    Herbal Doctor Remedies is recalling Psoriasis Balm because it was manufactured outside of current Good Manufacturing Practice controls.

    Product
    Psoriasis Balm, 60 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1599-2019·2019-08-14

    Herbal Doctor Remedies Recalls Hair Back Capsules for Manufacturing Deviations

    Herbal Doctor Remedies is recalling Hair Back 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.

    Product
    Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide