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.

5701–5725 of 21595

  • ModerateFDA (Drugs)·D-0426-2021·2021-06-02

    Cardinal Health Recalls Enoxaparin Syringes Due to Temperature Excursions

    Cardinal Health is recalling 64 boxes of Enoxaparin Dofium Injection 150mg/1ml syringes due to intermittent temperature excursions during storage.

    Product
    ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0533-2021·2021-06-02

    Cardinal Health Recalls Tobrex Ointment Due to Temperature Excursions

    Cardinal Health Inc. is recalling 28 tubes of Tobrex 0.3% Ophthalmic Ointment due to intermittent exposure to temperature excursions during storage.

    Product
    TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0558-2021·2021-06-02

    Cardinal Health Recalls Promethazine Oral Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling Promethazine Plain Oral Solution due to intermittent temperature excursions during storage.

    Product
    PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0544-2021·2021-06-02

    Cardinal Health Recalls Polyethylene Glycol 3350 Powder for Temperature Excursions

    Cardinal Health Inc. is recalling 163 bottles of Polyethylene Glycol 3350 Powder for Solution due to intermittent exposure to temperature excursions during storage.

    Product
    POLYETHYLENE GLYCOL 3350 — POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0434-2021·2021-06-02

    Cardinal Health Recalls Bevespi Aerosphere Due to Temperature Excursions

    Cardinal Health is recalling 355 inhalers of Bevespi Aerosphere due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    BEVESPI AEROSPHERE — BEVESPI AEROSPHERE (GLYCOPYRROLATE AND FORMOTEROL FUMARATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0504-2021·2021-06-02

    Cardinal Health Recalls Ferrous Sulfate Drops Due to Temperature Excursions

    Cardinal Health Inc. is recalling 357 bottles of Ferrous Sulfate Drops for infants and toddlers due to intermittent temperature excursions during storage.

    Product
    Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0532-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Supplements Due to Temperature Excursions

    Cardinal Health Inc. is recalling 205 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.

    Product
    Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0444-2021·2021-06-02

    Cardinal Health Recalls Benzefoam Emollient Foam Due to Temperature Excursions

    Cardinal Health Inc. is recalling Benzefoam Emollient Foam due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0431-2021·2021-06-02

    Cardinal Health Recalls Edarbyclor Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 273 bottles of Edarbyclor tablets due to intermittent exposure to temperature excursions during storage.

    Product
    EDARBYCLOR — EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0486-2021·2021-06-02

    Cardinal Health Recalls Triumeq Tablets Due to Temperature Excursions

    Cardinal Health is recalling 2,264 bottles of Triumeq tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    TRIUMEQ — TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0531-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Supplements Due to Temperature Excursions

    Cardinal Health Inc. is recalling 523 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.

    Product
    Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0393-2021·2021-06-02

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because customer complaints regarding ripped patches and adhesive issues exceeded action limits.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2021·2021-06-02

    Cardinal Health Recalls NURTEC ODT Due to Temperature Excursions

    Cardinal Health is recalling NURTEC ODT (rimegepant) tablets due to intermittent exposure to temperature excursions during storage.

    Product
    NURTEC ODT — NURTEC ODT (RIMEGEPANT SULFATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0628-2021·2021-06-02

    Brill Inc Recalls Chocolate Chip Cookies for Potential Foreign Objects

    Brill Inc is recalling specific batches of baked chocolate chip cookies due to the potential presence of small foreign objects.

    Product
    10239710: 12" BAKED CHOCOLATE CHIP MESSAGE COOKIE 14 / 22 oz BAKED CHOCOLATE CHIP COOKIES KEEP FROZEN AT 0¿F OR BELOW Net weight 19.25 lb (8.73 kg) (14 x 22 oz (624g)) and 10239711 9" CHOCOLATE CHIP BAKED MESSAGE COOKIE 16 / 12.5 oz BAKED CHOCOLATE CHIP COOKIES KEEP FROZEN AT 0¿F
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0436-2021·2021-06-02

    Cardinal Health Recalls XIGDUO Tablets Due to Temperature Excursions

    Cardinal Health is recalling 378 bottles of XIGDUO tablets due to intermittent exposure to temperature excursions during storage.

    Product
    XIGDUO — XIGDUO (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1680-2021·2021-06-02

    Nobel Biocare Procera Implant Crown Recalled for Manufacturing Defect

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

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - 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: 77364
    Category
    Medical Device
    Distribution
    Distributed nationwide