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.

201–225 of 4361

  • ModerateFDA (Devices)·Z-1836-2026·2026-04-29

    Medline Cardiac Catheterization Kits Recalled for Rescinded FDA Clearance

    Medline Industries is recalling 19,189 cardiac catheterization kits nationwide because certain syringe, guidewire, and tubing components had their FDA premarket notification (510(k)) clearances rescinded, meaning they were distributed without valid regulatory authorization.

    Product
    Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0462-2026·2026-04-22

    MGC Health Cough Drops Recalled Due to Manufacturing Quality Concerns

    MGC Health Cough Drops (Honey Lemon flavor, Lot 20240524) are being recalled nationwide following FDA inspection observations regarding product quality. Consumers should discontinue use of affected product.

    Product
    MGC HEALTH — MGC HEALTH (COUGH DROPS HONEY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0461-2026·2026-04-22

    MGC Health Cough Drops Recalled for Manufacturing Quality Observations

    MGC Health menthol cough drops are being recalled following FDA recommendations based on manufacturing facility inspection observations.

    Product
    MGC HEALTH — MGC HEALTH (COUGH DROPS HONEY SUGAR-FREE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2026·2026-04-22

    Remedy Gel hydrocortisone 1% recalled for subpotent drug content

    Island Kinetics' Remedy Gel hydrocortisone product (1,060 bottles, nationwide) is being recalled due to subpotency—the drug contains less active ingredient than labeled. This is a voluntary, firm-initiated recall.

    Product
    Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0468-2026·2026-04-22

    Quality Choice Cough Drops Recalled for Manufacturing Quality Concerns

    Quality Choice Honey Lemon Cough Drops (Lot 20240720, expires 07/20/2026) recalled nationwide following FDA inspection of manufacturing facility. No specific hazard details disclosed.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS HONEY LEMON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0467-2026·2026-04-22

    Quality Choice Cough Drops Creamy Strawberry Recalled for Manufacturing Quality Issue

    Quality Choice Cough Drops Creamy Strawberry (Lot #20240720) are being recalled nationwide due to observations during FDA manufacturing facility inspection on August 15, 2025.

    Product
    QUALITY CHOICE COUGH DROPS CREAMY STRAWBERRY — QUALITY CHOICE COUGH DROPS CREAMY STRAWBERRY (COUGH DROPS CREAMY STRAWBERRY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0470-2026·2026-04-22

    Quality Choice Cough Drops Vanilla Honey Recalled for Manufacturing Quality Concern

    FDA has recalled Quality Choice Cough Drops Vanilla Honey (lot 20240720) nationwide due to manufacturing quality observations found during a facility inspection on August 15, 2025.

    Product
    QUALITY CHOICE COUGH DROPS VANILLA HONEY — QUALITY CHOICE COUGH DROPS VANILLA HONEY (COUGH DROPS VANILLA HONEY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2026·2026-04-22

    FDA Recalls Skin Rehab Hydrocortisone Balm Nationwide for Subpotency

    Island Kinetics is recalling Skin Rehab Calming Skin Gel nationwide due to subpotency. The product labeled as containing 1% hydrocortisone actually contains less active ingredient than stated.

    Product
    Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2026·2026-04-22

    FDA Recalls Magnesium Chloride Bulk API for Subpotency

    Avantor Performance Materials LLC has recalled Magnesium Chloride, 6-Hydrate crystals (36 bottles) due to subpotency. The bulk active pharmaceutical ingredient does not contain the full labeled potency.

    Product
    Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2026·2026-04-22

    Cough drop product recalled due to manufacturing facility quality observations

    The FDA is recalling Quality Choice menthol cough drops (NDC 83698-675-30) distributed nationwide. The recall was prompted by inspection findings at the manufacturing facility related to product quality.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1825-2026·2026-04-22

    Philips Spectral CT on Rails Software Issues Recall

    Philips Medical Systems recalls three Spectral CT on Rails systems due to software defects in version 5.1.X affecting gantry positioning and imaging controls. Systems are distributed worldwide including Minnesota, France, and the Netherlands.

    Product
    Philips Spectral CT on Rails. Model Number: 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0664-2026·2026-04-22

    Bee Well Wildflower Honey recalled for high C4 sugar content

    Bee Well Honey Farm & Supply Inc. is recalling Raw & Unfiltered Bee Well Wildflower Honey in 12, 22, and 44 oz sizes distributed to South Carolina retailers after FDA testing found high C4 sugar content in samples.

    Product
    Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0477-2026·2026-04-22

    Prescription Fluocinonide Cream Recalled for Failed Viscosity Specifications

    SUN PHARMACEUTICAL is recalling Fluocinonide cream (0.05%) due to out-of-specification viscosity levels found during stability testing. The affected product was distributed nationwide.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0464-2026·2026-04-22

    Quality Choice Cough Drops Recalled Due to Manufacturing Quality Concerns

    Quality Choice Sugar-Free Cough Drops are being recalled due to observations made during a manufacturing facility inspection. The recall affects cough drops distributed nationwide in the U.S.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS HONEY LEMON SUGAR FREE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2026·2026-04-22

    Drug Recall: Essential Calming Skin Gel Contains Subpotent Hydrocortisone

    Island Kinetics, Inc. is recalling Essential Calming Skin Gel due to subpotent hydrocortisone. The affected 120mL jars (Lot 4212D4) were distributed nationwide and contain less active ingredient than labeled.

    Product
    Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0456-2026·2026-04-22

    Honey Lemon Cough Drops Recalled Due to Manufacturing Quality Concerns

    Xiamen Kang Zhongyuan Biotechnology is recalling Honey Lemon Flavor Cough Drops following FDA observations about manufacturing facility quality. The recall affects lot 20241030 distributed nationwide.

    Product
    HONEY LEMON FLAVOR COUGH DROP — HONEY LEMON FLAVOR COUGH DROP (HONEY LEMON FLAVOR COUGH DROP)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0466-2026·2026-04-22

    Quality Choice Cough Drops Sugar Free Recalled for Manufacturing Quality Issues

    Quality Choice Cough Drops in honey lemon sugar-free flavor are being recalled due to observations from a manufacturing facility inspection. No illnesses or injuries have been reported.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS HONEY LEMON SUGAR FREE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0457-2026·2026-04-22

    Menthol Flavor Cough Drops Recalled for Quality Defect

    The FDA is recalling Menthol Flavor Cough Drops (Lot #20241030) manufactured for military exchanges due to quality observations identified during a facility inspection on August 15, 2025.

    Product
    MENTHOL FLAVOR COUGH DROP — MENTHOL FLAVOR COUGH DROP (MENTHOL FLAVOR COUGH DROP)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2026·2026-04-22

    Prescription nasal spray recalled for defective bottle caps

    Apotex Corp. is recalling one lot of Desmopressin Acetate Nasal Spray due to defective bottle caps with dislodged or missing cap liners. Affected patients should contact their pharmacy or healthcare provider.

    Product
    DESMOPRESSIN ACETATE — DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0475-2026·2026-04-22

    Fluocinonide Cream Recalled Due to Failed Viscosity Specifications

    SUN Pharmaceutical is recalling 24,672 tubes of Fluocinonide 0.05% cream (Lot AD76252) distributed nationwide due to viscosity test failures discovered during stability testing.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2026·2026-04-22

    Blemish Spot Treatment Recalled Due to Failed Stability Specifications

    Island Kinetics is recalling Blemish Spot Treatment (Salicylic Acid) 1% due to failed stability specifications. Approximately 28,163 bottles distributed nationwide are affected.

    Product
    Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0463-2026·2026-04-22

    FDA Recalls MGC Health Menthol Cough Drops for Quality Concerns

    The FDA recalled MGC Health Menthol Cough Drops nationwide following inspection observations that may affect product quality. The affected lot number is 20240730 with expiration date July 30, 2026.

    Product
    MGC HEALTH — MGC HEALTH (COUGH DROPS HONEY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1810-2026·2026-04-22

    LinkBio CORE Workstation may display incorrect planning dates

    The LinkBio CORE Workstation, a surgical planning device used in shoulder procedures, may display incorrect planning dates in its menu system. Five units have been distributed in Alabama, Florida, and Kansas.

    Product
    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
    Category
    Medical Device
    Distribution
    Distributed nationwide