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.

5751–5775 of 21595

  • ModerateFDA (Drugs)·D-0540-2021·2021-06-02

    Cardinal Health Recalls HySept Solution Due to Temperature Excursions

    Cardinal Health is recalling 236 bottles of HySept Solution 0.25% Sodium Hypochlorite due to intermittent temperature excursions during storage.

    Product
    HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1681-2021·2021-06-02

    Nobel Biocare Procera LLC Recalls Implant Crowns Not Manufactured to Specification

    Nobel Biocare Procera LLC is recalling specific implant crowns because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0457-2021·2021-06-02

    Cardinal Health Recalls Jentadueto XR Due to Temperature Excursions

    Cardinal Health Inc. is recalling 52 bottles of Jentadueto XR tablets due to intermittent exposure to temperature excursions during storage.

    Product
    JENTADUETO XR — JENTADUETO XR (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0449-2021·2021-06-02

    Cardinal Health Recalls Belbuca Due to Temperature Excursions

    Cardinal Health is recalling 47 cartons of Belbuca (buprenorphine hydrochloride) buccal film due to intermittent exposure to temperature excursions during storage.

    Product
    BELBUCA — BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0546-2021·2021-06-02

    Cardinal Health Recalls Fexofenadine Tablets Due to Temperature Excursions

    Cardinal Health is recalling 321 bottles of Fexofenadine Hydrochloride 180 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1674-2021·2021-06-02

    Siemens Centaur Syphilis Assay Recalled for Potential Carryover Interference

    Siemens Healthcare Diagnostics is recalling the Centaur Syphilis Assay-SYP Kit due to potential carryover into other assays on specific systems.

    Product
    Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0448-2021·2021-06-02

    Cardinal Health Recalls Belbuca Due to Temperature Excursions

    Cardinal Health is recalling 96 cartons of Belbuca buccal film due to intermittent exposure to temperature excursions during storage.

    Product
    BELBUCA — BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0505-2021·2021-06-02

    Cardinal Health Recalls Siladryl Liquid Due to Temperature Excursions

    Cardinal Health is recalling 78 bottles of Siladryl 12.5/5ml liquid because of intermittent temperature excursions during storage.

    Product
    SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0573-2021·2021-06-02

    Cardinal Health Recalls Proair HFA Inhalers Due to Temperature Excursions

    Cardinal Health Inc. is recalling 26,895 Proair HFA inhalers due to intermittent exposure to temperature excursions during storage.

    Product
    Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0515-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 53 bottles of Vitamin D3 25mcg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0482-2021·2021-06-02

    Cardinal Health Recalls Trelegy Ellipta Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 903 Trelegy Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent exposure to temperature excursions during storage.

    Product
    TRELEGY ELLIPTA — TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE)
    Category
    Drug
    Distribution
    3 states