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.

7976–8000 of 21595

  • ModerateFDA (Devices)·Z-0256-2020·2019-11-06

    Centurion Medical Recalls Port Access Infusion Kits with 1-Inch Needles

    Centurion Medical Products Corporation is recalling 200 Port Access Infusion Kits with 1-inch needles distributed in Illinois due to a supplier-initiated recall.

    Product
    PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0078-2020·2019-11-06

    Blue Bell Butter Crunch Ice Cream Recalled for Possible Foreign Material

    Blue Bell Creameries is recalling specific lots of Butter Crunch Ice Cream due to possible foreign material in the product.

    Product
    Blue Bell Butter Crunch Ice Cream packaged in a 1/2 Gallon (2 Qts) paperboard cup & lid (4 units per corrugated sleeve, 77 sleeves per pallet).
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0250-2020·2019-11-06

    Cordis MAXI LD PTA Dilatation Catheter Recalled for Expired Component

    Cordis Corporation is recalling 21 units of MAXI LD PTA Dilatation Catheters because they were manufactured using an expired inner body.

    Product
    Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0081-2020·2019-11-06

    Jack Daniels Tennessee Whiskey Cake Recalled for Potential Mold

    The Great Spirits Baking Company is recalling Jack Daniels Tennessee Whiskey Cake - Vanilla due to potential mold growth before the expiration date.

    Product
    Jack Daniels Tennessee Whiskey Cake - Vanilla - Net Wt 8 OZ (227 g), UPC: 854621004356
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0298-2020·2019-11-06

    Taro Recalls Ibuprofen Oral Suspension Due to Foreign Plastic Particles

    Taro Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·107-2019·2019-11-04

    Padrino Foods Recalls Beef Tamales Due to Pork Mislabeling

    Padrino Foods is recalling beef tamales labeled as beef and sirloin that contain pork. The recall affects products sold in Kansas, Louisiana, Oklahoma, and Texas.

    Product
    Padrino Foods LLC — Padrino Foods, LLC Recalls Beef Tamales Products due to Mislabeling
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0069-2020·2019-10-30

    Kenzen Calcium Complex Recalled for Missing Milk Allergen Labeling

    HP Ingredients is recalling Kenzen Calcium Complex tablets because the label lacks the required 'Contains: milk' advisory.

    Product
    NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads "Contains ingredients derived from dairy" under Recommended Use.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0160-2020·2019-10-30

    Siemens Mammomat Revelation Recall for Biopsy Software Error

    Siemens is recalling Mammomat Revelation mammography systems with specific software due to a rare error that can make the workstation unresponsive during biopsies.

    Product
    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects

    Andover Healthcare Inc. is recalling 1,050 cases of Sterile Co-Flex Med 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0071-2020·2019-10-30

    Sugar Mill Farms Focused Energy Recalled for Undeclared Yellow #6

    Hall Global, LLC is recalling Sugar Mill Farms Focused Energy hemp extract products because the label fails to declare Yellow #6 and lists incorrect ingredients and flavors.

    Product
    Sugar Mill Farms Focused Energy 25 mg Hemp Extract Berry Flavor 7.25 g 5 blast cap count
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0070-2020·2019-10-30

    Hall Global Recalls OXZGEN CBD Capsules for Labeling Errors

    Hall Global, LLC is recalling OXZGEN Performance CBD capsules because the label fails to declare Yellow #6 and lists an incorrect amount of Vitamin B2.

    Product
    OXZGEN Performance 25 mg Hemp Derived CBD + Teacrine + BCAA Orange Flavored, 5 blast caps, 2.2 FL OZ
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0041-2020·2019-10-23

    CTC Food International Recalls Orchids Dried Mushroom for Undeclared Sulfites

    CTC Food International is recalling Orchids Dried Mushroom because it contains undeclared sulfites. The recall covers 28,800 units distributed to eight U.S. states.

    Product
    Orchids Dried Mushroom NET WT. 1 oz. (29G) Product of China UPC 0-74601-00947-2 Distributed by CTC Food International, Inc. Richmond, CA 94804
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0123-2020·2019-10-23

    Medtronic Solarice Balloon Catheter Recall Due to Stylette Removal Difficulty

    Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette may cause removal difficulties.

    Product
    Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC25
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0143-2020·2019-10-23

    Aurobindo Recalls Amphetamine Mixed Salts Tablets for Out-of-Specification Weight

    Aurobindo Pharma USA Inc. is recalling 11,129 bottles of 20mg Amphetamine Mixed Salts tablets because they failed weight and thickness specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0155-2020·2019-10-23

    Vital Scientific Viva-E Automated Chemistry Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling 75 Viva-E automated chemistry analyzers due to power supply failures that prevent the instruments from producing patient results.

    Product
    Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0156-2020·2019-10-23

    Vital Scientific V-Twin Automated Chemistry Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling 39 V-Twin automated chemistry analyzers due to a power supply failure that prevents the instruments from producing patient results.

    Product
    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2020·2019-10-23

    Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Pantoprazole Sodium Delayed Release Tablets due to dark brown discoloration on tablet edges.

    Product
    Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0154-2020·2019-10-23

    Vital Scientific Viva-JR Automated Chemistry Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling four Viva-JR automated chemistry analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

    Product
    Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0158-2020·2019-10-23

    Vital Scientific Selectra ProS Analyzer Recalled for Power Supply Failure

    Vital Scientific is recalling six Selectra ProS Analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

    Product
    Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2020·2019-10-23

    Atlas Pharmaceuticals Recalls Ascorbic Acid Injection Due to Corn Source Labeling Error

    Atlas Pharmaceuticals is recalling Ascorbic Acid Sterile Injection Solution vials labeled as 'Non-Corn Source' but actually derived from corn. The recall affects 1,646 vials distributed to healthcare facilities in Arizona and Colorado.

    Product
    Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0146-2020·2019-10-23

    Ingenus Recalls Leucovorin Calcium Injection Due to Crystallization

    Ingenus Pharmaceuticals is recalling Leucovorin Calcium Injection vials due to the presence of particulate matter identified as API crystallization.

    Product
    Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0035-2020·2019-10-23

    Arcadia Trading Recalls Dried Mushroom Bags for Undeclared Sulfites

    Arcadia Trading Inc. is recalling 1,425 bags of dried mushrooms because they contain undeclared sulfites. The product was distributed to a New York distributor and further distributed in seven states.

    Product
    Dried Mushroom NET WT: 8oz (227g) Ingredients: Mushroom Distributed By: Arcadia Trading Inc. Brooklyn, NY 11211. USA Product of China UPC: 791804603091
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-0049-2020·2019-10-23

    Climax Spring Water Recalled for Excessive Bromate Levels

    King Bottling, Inc. is recalling Climax Spring Water in various sizes because it contains bromate levels above the FDA standard of quality limit.

    Product
    Climax Spring Water bottled in 5 gallon, 1 gallon, and 16.9 ounce plastic bottles (12 bottles per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0050-2020·2019-10-16

    Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

    Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.

    Product
    EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent adminis
    Category
    Medical Device
    Distribution
    Distributed nationwide