The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

21926–21950 of 88183

  • HighFDA (Drugs)·D-0041-2023·2022-11-09

    Compounded injectable medication recalled for lack of sterility assurance

    Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.

    Product
    PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0053-2023·2022-11-09

    Semaglutide Injection Recalled Due to Sterility Assurance Deficiency

    The FDA is recalling semaglutide injection from Vital Care Compounder for lack of assurance of sterility. The recall affects specific lots distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0162-2023·2022-11-09

    Medline Lithotomy Sterile Surgical Kit Recalled for Compromised Breather Pouch Seal

    Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.

    Product
    MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2023·2022-11-09

    Compounded sterile drug solution recalled due to manufacturing sterility failure

    Vital Care Compounder is recalling Brilliant Blue G Solution due to inability to assure product sterility. The recall involves 86 vials (Lot 60448) distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0038-2023·2022-11-09

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.

    Product
    METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-0105-2023·2022-11-09

    Bella Cucina Pizza Mix Recalled for Undeclared Wheat Allergen

    Bella Cucina Tradizionale Pizza and Foccacia Mix is being recalled because the label does not declare wheat, a common allergen. Consumers with wheat allergies could experience allergic reactions.

    Product
    Bella Cucina Artful Food Tradizionale Pizza and Foccacia Mix Net Wt. 15 oz 422g can, Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Drugs)·D-0056-2023·2022-11-09

    FDA Recalls Vancomycin Intravitreal Injections for Sterility Defect

    Pharmacy Plus Inc. is recalling vancomycin intravitreal eye injections due to FDA findings that sterility cannot be assured. The products were produced in a manner that does not guarantee they remain sterile.

    Product
    VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0047-2023·2022-11-09

    Papaverine HCL Stock Solution Recalled Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Papaverine HCL Stock Solution 30mg/ml vials due to lack of sterility assurance. FDA inspection found the product was produced in a manner that cannot guarantee sterility.

    Product
    PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-0119-2023·2022-11-09

    HP Hood Chive Cottage Cheese Recalled for Plastic Contamination

    HP Hood LLC is recalling chive cottage cheese sold under multiple store brands due to potential plastic contamination. Approximately 391,824 cases distributed across 37 states.

    Product
    Food Club Chive Cottage Cheese, 16 oz; Hannaford Chive Cottage Cheese, 16 oz; Hood Chive Cottage Cheese, 16 oz and 24 oz; Price Chopper Chive Cottage Cheese, 16 oz; Market Basket CChive Cottage Cheese, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Drugs)·D-0045-2023·2022-11-09

    Injectable Drug Recalled Over Failure to Assure Product Sterility

    Vital Care Compounder is recalling a compounded injectable medication due to FDA findings that the manufacturing process failed to guarantee sterility. Two lots were distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-0098-2023·2022-11-09

    Bella Cucina Fresh Basil Pesto Recalled for Undisclosed Milk Allergen

    Bella Cucina Artful Food is recalling Fresh Basil Pesto because the label does not disclose milk. The product may cause allergic reactions in consumers with milk allergies.

    Product
    Bella Cucina Artful Food Fresh Basil Pesto Net Wt. 3 oz (84.5g) bag, UPC 6 19193 00211 3 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0100-2023·2022-11-09

    Bella Cucina Spinach Artichoke Bruschetta Spread Recalled for Undisclosed Milk

    Bella Cucina Artful Food is recalling Spinach Artichoke Bruschetta Spread because the label does not indicate milk. Consumers with milk allergies should not consume this product.

    Product
    Bella Cucina Artful Food Spinach Artichoke Bruschetta Spread Net Wt. 10 oz (286g) jar, UPC 6 19193 00501 5 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Devices)·Z-0147-2023·2022-11-09

    Fogarty Biliary Balloon Probes recalled for latex deterioration

    Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.

    Product
    Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2023·2022-11-09

    Pediatric Vision Scanner Battery Pack Poses Fire Risk

    Rebiscan is recalling Blinq Pediatric Vision Scanners (Model BQ830) because the battery pack may vent and catch fire if a cell voltage drops below 2.5V.

    Product
    Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2023·2022-11-09

    Ranibizumab eye implant recalled for non-functioning delivery system

    Genentech is recalling Susvimo ocular implants (452 units nationwide) due to manufacturing defects in the drug delivery system. A few patients have experienced non-functioning implants.

    Product
    SUSVIMO — SUSVIMO (RANIBIZUMAB)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2023·2022-11-09

    BD Multitest 6-Color TBNK tubes recalled for partial label detachment

    BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.

    Product
    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Food)·F-0141-2023·2022-11-02

    Earth Grown Vegan Falafel Recalled for E. Coli Contamination

    Earth Grown Vegan Garlic & Herb Falafel is being recalled due to possible contamination with Shiga toxin-producing E. coli. The recall affects over 190,000 units distributed across multiple US states.

    Product
    Earth Grown Vegan Garlic & Herb Falafel NET WT 12 OZ (340g), 12 pieces UPC:4 0991002 24344
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-0140-2023·2022-11-02

    Earth Grown Vegan Falafel Recalled for Possible E. coli Contamination

    Earth Grown Vegan Traditional Falafel is being recalled due to possible contamination with Shiga toxin-producing E. coli. The FDA Class I recall affects approximately 190,860 units distributed across multiple U.S. states.

    Product
    Earth Grown Vegan Traditional Falafel NET WT 12 OZ (340g), 12 pieces UPC:4 0991002 24337
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-0117-2023·2022-11-02

    Caribou Coffee Snack Fruit and Cheese Plate Recalled for Listeria Risk

    Cut Fruit Express is recalling Caribou Coffee Snack Fruit and Cheese Plates due to potential Listeria in the Brie cheese. Affected units were distributed in Minnesota with Use By dates from September 30 to October 9, 2022.

    Product
    Caribou Coffee Snack Fruit and Cheese Plate, item # 3818, Net Wt 6.2 oz. (176g) 3 cheeses, red grapes, apples, rosemary crackers. Keep Refrigerated. Manufactured By: Cut Fruit Express, Inver Grove Heights, MN
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0019-2023·2022-11-02

    Atenolol 25mg bottles mislabeled; contain Clopidogrel 75mg tablets

    Golden State Medical Supply Inc. is recalling 2,584 bottles of Atenolol 25mg tablets nationwide. Bottles labeled as Atenolol 25mg actually contain Clopidogrel 75mg tablets—a different medication.

    Product
    ATENOLOL — ATENOLOL (ATENOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2023·2022-11-02

    Sodium Bicarbonate Injection Recalled for Defective Vials and Glass Breakage

    Nationwide recall of 8.4% sodium bicarbonate injection vials due to container defects causing vial breakage and glass fragments when pressurized during preparation.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0022-2023·2022-11-02

    Sodium Bicarbonate Injection Recalled for Defective Vials with Glass Breakage Risk

    Exela Pharma Sciences is recalling 2,123,040 vials of Sodium Bicarbonate 8.4% Injection due to container defects causing vial breakage and glass release when pressurized during product preparation.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0124-2023·2022-11-02

    Medline Pre-Op CHG Bathing Kit recalled for incorrect expiration dates

    Medline is recalling 460 Pre-Op CHG Bathing Kits because the CHG solution and blood culture bottles have expiration dates that don't match the kit label. Expired components could compromise effectiveness.

    Product
    MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2023·2022-11-02

    Medline Blood Culture Kits recalled due to mismatched component expiration dates

    Medline Industries is recalling 1,600 blood culture kits (Reorder # DYNDH1592) because component expiration dates don't match the kit label. Affected components include CHG Solution and Bactec bottle plastic.

    Product
    MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2023·2022-11-02

    ARTIS pheno interventional x-ray system software defect prevents treatment continuation

    Siemens is recalling ARTIS pheno x-ray systems with VE10B software due to three potential software issues that may prevent continued treatment on the affected system, potentially requiring use of an alternate system.

    Product
    ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide