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.

5651–5675 of 21589

  • ModerateFDA (Drugs)·D-0418-2021·2021-06-02

    Cardinal Health Recalls Namzaric Due to Temperature Excursions

    Cardinal Health is recalling 659 bottles of Namzaric capsules due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    NAMZARIC — NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0529-2021·2021-06-02

    Cardinal Health Recalls Proctofoam Aerosol Due to Temperature Excursions

    Cardinal Health is recalling 834 containers of Proctofoam HC aerosol due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    PROCTOFOAM — PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0487-2021·2021-06-02

    Cardinal Health Recalls Hydrocortisone Ointment Due to Temperature Excursions

    Cardinal Health Inc. is recalling 23 tubes of Hydrocortisone Ointment USP 1% due to intermittent exposure to temperature excursions during storage.

    Product
    Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0461-2021·2021-06-02

    Cardinal Health Recalls Valsartan Tablets Due to Temperature Excursions

    Cardinal Health is recalling Valsartan 40 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0452-2021·2021-06-02

    Cardinal Health Recalls CATAPRES-TTS-2 Patches Due to Temperature Excursions

    Cardinal Health is recalling CATAPRES-TTS-2 adhesive patches due to intermittent exposure to temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0537-2021·2021-06-02

    Cardinal Health Recalls Benztropine Mesylate Tablets Due to Storage Temperature Excursions

    Cardinal Health is recalling Benztropine Mesylate Tablets due to intermittent exposure to temperature excursions during storage. The affected products were distributed to Florida, Georgia, and South Carolina.

    Product
    Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0554-2021·2021-06-02

    Cardinal Health Recalls Chantix Tablets Due to Temperature Excursions

    Cardinal Health is recalling 940 cartons of Chantix (varenicline) tablets due to intermittent temperature excursions during storage. The affected products were distributed in Florida, Georgia, and South Carolina.

    Product
    Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0547-2021·2021-06-02

    Cardinal Health Recalls Loratadine Tablets Due to Temperature Excursions

    Cardinal Health is recalling 2,854 bottles of Loratadine 10mg tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0454-2021·2021-06-02

    Cardinal Health Recalls Atrovent HFA Inhalers Due to Temperature Excursions

    Cardinal Health Inc. is recalling 667 Atrovent HFA inhalers due to intermittent exposure to temperature excursions during storage.

    Product
    ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0564-2021·2021-06-02

    Cardinal Health Recalls Cefazolin Injection Due to Temperature Excursions

    Cardinal Health Inc. is recalling Cefazolin for Injection due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    CEFAZOLIN — CEFAZOLIN (CEFAZOLIN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0420-2021·2021-06-02

    Cardinal Health Recalls Vraylar Capsules Due to Temperature Excursions

    Cardinal Health is recalling 759 bottles of Vraylar (cariprazine) capsules due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0569-2021·2021-06-02

    Cardinal Health Recalls COREG CR Capsules Due to Temperature Excursions

    Cardinal Health is recalling 133 bottles of COREG CR 80 mg capsules due to intermittent temperature exposure during storage.

    Product
    COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0586-2021·2021-06-02

    Cardinal Health Recalls Tramadol Hydrochloride Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 86 bottles of Tramadol Hydrochloride 100mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0447-2021·2021-06-02

    Cardinal Health Recalls Dexamethasone Sodium Phosphate Eye Drops

    Cardinal Health Inc. is recalling 318 droptainers of Dexamethasone Sodium Phosphate 0.1% eye drops due to temperature excursions during storage.

    Product
    DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1677-2021·2021-06-02

    Nobel Biocare Procera Recalls Two Dental Implant Crowns for Specification Defects

    Nobel Biocare Procera LLC is recalling two dental implant crown units because they were not manufactured to specification. The affected units were distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - 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: 77339
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2021·2021-06-02

    Cardinal Health Recalls FaBB Vitamin B6 Supplement Due to Temperature Excursions

    Cardinal Health is recalling 54 bottles of FaBB Vitamin B6, Folic Acid, and Vitamin B12 dietary supplements due to intermittent temperature excursions during storage.

    Product
    FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117
    Category
    Drug
    Distribution
    3 states