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.

5801–5825 of 21595

  • ModerateFDA (Drugs)·D-0471-2021·2021-06-02

    Cardinal Health Recalls Ivermectin Tablets Due to Temperature Excursions

    Cardinal Health is recalling 504 cartons of Ivermectin Tablets USP 3 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0428-2021·2021-06-02

    Cardinal Health Recalls Timolol Maleate Ophthalmic Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 droptainers of Timolol Maleate Ophthalmic Solution 0.5% due to intermittent exposure to temperature excursions during storage.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0456-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 284 bottles of Synjardy tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
    Category
    Drug
    Distribution
    3 states
  • 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 (Drugs)·D-0460-2021·2021-06-02

    Cardinal Health Recalls Pravachol 40mg Tablets Due to Temperature Excursions

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

    Product
    PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0421-2021·2021-06-02

    Cardinal Health Recalls Nitrofurantoin Capsules Due to Storage Temperature Excursions

    Cardinal Health Inc. is recalling 15 bottles of Nitrofurantoin Macrocrystals Capsules 25 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0481-2021·2021-06-02

    Cardinal Health Recalls Trelegy Ellipta Due to Temperature Excursions

    Cardinal Health Inc. is recalling 4,065 cartons of Trelegy Ellipta inhalers 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
  • ModerateFDA (Drugs)·D-0499-2021·2021-06-02

    Cardinal Health Recalls Auryxia Tablets Due to Temperature Excursions

    Cardinal Health is recalling 136 bottles of Auryxia (ferric citrate) 210 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0521-2021·2021-05-26

    Newly Weds Breader Crumbs Recalled for Foreign Material

    Newly Weds Foods Inc. is recalling 142 bags of B70709 breader crumbs due to the presence of foreign material. The product was distributed to manufacturers and distributors in 17 states and Mexico.

    Product
    Newly Weds B70709 breader crumbs X3, 40lbs bag
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0517-2021·2021-05-26

    Newly Weds Breader X1 Recalled for Foreign Material

    Newly Weds Foods Inc. is recalling 124 bags of Breader X1 due to the presence of foreign material. The product was distributed to manufacturers and distributors in 17 U.S. states and Mexico.

    Product
    Newly Weds B53339 breader X1, 40lbs bag
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0533-2021·2021-05-26

    Newly Weds Pecan Crusted Mix Recalled for Foreign Material

    Newly Weds Foods is recalling Pecan Crusted Mix due to potential foreign material contamination. The voluntary recall affects 121 units distributed across 17 states and Mexico.

    Product
    Newly Weds G52587 PECAN CRUSTED MIX X1, 4, 3lbs bag per unit
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0516-2021·2021-05-26

    Newly Weds Breader Recalled for Foreign Material

    Newly Weds Foods Inc is recalling 250 bags of Breader X1 due to the presence of foreign material. The product was distributed to manufacturers and distributors in 17 states and Mexico.

    Product
    Newly Weds B52792 breader X1, 35lbs bag
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0553-2021·2021-05-26

    Udi Gluten Free Blueberry Muffins Recalled for Potential Plastic Presence

    Conagra Brands is recalling Udi Gluten Free Blueberry Muffins due to the potential presence of plastic. Consumers should check lot codes and stop eating the product.

    Product
    Udi Gluten Free Blueberry Muffins, 10oz (284g) retail container of 4 muffins, 6 retail units per wholesale case. Retail unit UPC: 00-6-98997-81038-4 (domestic) 00-6-98997-81044-5 (Canada)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·021-2021·2021-05-26

    Legacy Food Company Recalls Beef Jerky for Undeclared Sesame Oil

    Legacy Food Company is recalling beef jerky products because they contain sesame oil, which is not listed on the label.

    Product
    Legacy Food Company Inc, — Legacy Food Company, Inc. Recalls Beef Jerky Products Due to Misbranding and an Undeclared Ingredient
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0495-2021·2021-05-26

    Kewpie Roasted Sesame Dressing Recalled for Pesticide Regulation Deviation

    Kewpie Roasted Sesame Dressing is being recalled because certain lots exceeded European ethylene oxide regulations.

    Product
    Kewpie Deep Roasted Sesame Dressing; 8 oz.(263ml/243g) and 64 oz. (1893 ml/1950g) bottles (glass and plastic) Refrigerate after opening. UPC 8 oz: 8 719189 240153 UPC 64 oz. 8 719189 24160 Manufactured by Q&B Foods Inc. 15547 First St., Irwindale, CA 91706
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1659-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling specific Groshong NXT ClearVue catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0514-2021·2021-05-26

    Newly Weds Bread Crumbs Recalled for Foreign Material

    Newly Weds Foods Inc is recalling 125 bags of 40lb bread crumbs due to foreign material. The voluntary recall covers distributors in 17 US states and Mexico.

    Product
    Newly Weds A70178 bread crumbs X1, 40lbs bag
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0543-2021·2021-05-26

    21st Century Vitamin D3 Tablets Recalled for Incorrect Labeling

    Twenty-First Century Healthcare is recalling 21st Century Vitamin D3 tablets because some bottles were mislabeled with a lower dosage.

    Product
    21st Century Vitamin D3 125 mcg (5000 IU) tablet, 100 count, UPC 7-40985-27431-6, 21st Century HealthCare, Inc., 2119 Wilson St., Tempe, AZ 85282
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1593-2021·2021-05-26

    Gore Viabil Biliary Endoprosthesis Recalled for Length Discrepancy

    W.L. Gore & Associates is recalling 61 Gore Viabil Biliary Endoprosthesis devices because a complaint reported a device appeared shorter than its labeled length.

    Product
    GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0513-2021·2021-05-26

    Newly Weds Bread Crumbs Recalled for Foreign Material

    Newly Weds Foods Inc is recalling 59 bags of bread crumbs due to the presence of foreign material. The product was distributed to manufacturers and distributors in 17 states and Mexico.

    Product
    Newly Weds A70088 bread crumbs X1, 35lbs bag
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0528-2021·2021-05-26

    Newly Weds Bread Crumbs Recalled for Foreign Material

    Newly Weds Foods Inc. is recalling 50-pound bags of bread crumbs due to the presence of foreign material. The recall covers 3,592 bags distributed to manufacturers and distributors in 17 U.S. states and Mexico.

    Product
    Newly Weds B70971 bread crumbs X1, 50lbs bag
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0534-2021·2021-05-26

    Newly Weds Stuffed Crab Seasoning Recalled for Foreign Material

    Newly Weds Foods Inc is recalling 43 bags of Stuffed Crab Seasoning due to the presence of foreign material. The product was distributed to manufacturers and distributors in 17 U.S. states and Mexico.

    Product
    Newly Weds G94866 Stuffed Crab Seasoning X1, 34.45lbs bag
    Category
    Food
    Distribution
    16 states