The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

39051–39075 of 50506

  • HighFDA (Devices)·Z-1493-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 172 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-939-2015·2015-04-29

    Tranilast API Recalled for Potential Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling Tranilast active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Tranilast active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-670-2015·2015-04-29

    Ezetimibe API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Ezetimibe active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Ezetimibe active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-543-2015·2015-04-29

    Attix Pharmaceuticals Recalls Bimatoprost API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Bimatoprost active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Bimatoprost active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-507-2015·2015-04-29

    Aldosterone API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Aldosterone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Aldosterone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-936-2015·2015-04-29

    Attix Pharmaceuticals Recalls Topiramate API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Topiramate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Topiramate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-631-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dimethyl Fumarate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Dimethyl Fumarate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Dimethyl Fumarate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2013-2015·2015-04-29

    Ateeco Recalls Mrs. T's Pierogies Due to Plastic Contamination

    Ateeco, Inc. is voluntarily recalling specific lots of Mrs. T's Mozzarella, Tomato & Basil Pierogies due to plastic contamination that may pose a choking hazard.

    Product
    Mrs. Ts Pierogies, Net Wt 16 oz (1 lb) 456 g,12 Pieces/ Carton 12 Cartons/ Case, frozen, Best By: 05/20/16, 07/15/16, 08/27/16 UPC: 4116400042
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-644-2015·2015-04-29

    Attix Pharmaceuticals Recalls D-Penicillamine Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling D-Penicillamine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    D-Penicillamine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-734-2015·2015-04-29

    Irbesartan API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Irbesartan active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Irbesartan active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets

    Churchill Medical Systems is recalling 2,350 units of 4-inch Microbore Double Lumen Sets due to a potential leak caused by an insufficient bond between the needleless device and the female luer.

    Product
    4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 52 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-940-2015·2015-04-29

    Trazodone HCl Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Trazodone HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Trazodone HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-598-2015·2015-04-29

    Attix Pharmaceuticals Recalls Clozapine API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Clozapine active pharmaceutical ingredient repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Clozapine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-502-2015·2015-04-29

    Adapalene API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling all lots of Adapalene active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Adapalene active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-551-2015·2015-04-29

    Attix Pharmaceuticals Recalls Bupivacaine Ingredient Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Bupivacaine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging. The product was distributed nationwide to compounding pharmacies and research organizations.

    Product
    Bupivacaine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2026-2015·2015-04-29

    Dairy Farmers of America Recalls Borden Good 2 Gether Snack Trays

    Dairy Farmers of America is recalling Borden Good 2 Gether snack trays due to a potential hard plastic fragment that could cause choking.

    Product
    Borden Good 2 Gether, UPC: 5300001112, Sharp Cheddar Cheese with Pretzels, Net Wt 2 0z (57 g), Dist. By DFA Dairy Farmers of America, PO Box 909700, Kansas City, MO 64190.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1473-2015·2015-04-29

    Churchill Medical Systems Recalls 7-Inch High Pressure Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 129,500 units of 7-inch High Pressure Sets with Bionector due to a potential for leaking caused by insufficient bonding.

    Product
    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-808-2015·2015-04-29

    Attix Pharmaceuticals Recalls Moxifloxacin HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Moxifloxacin HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Moxifloxacin HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-614-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dapsone API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Dapsone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Dapsone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-582-2015·2015-04-29

    Cholestyramine API Recalled for Potential Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling Cholestyramine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Cholestyramine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-506-2015·2015-04-29

    Attix Pharmaceuticals Recalls Albuterol Sulfate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Albuterol Sulfate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Albuterol Sulfate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2019-2015·2015-04-29

    Rising Moon Organics Spinach and Cheese Ravioli Recalled for Listeria

    Carmel Food Group is recalling Rising Moon Organics Spinach & Cheese Ravioli because the spinach used contained Listeria monocytogenes.

    Product
    Rising Moon Organics Spinach & Cheese Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 55561 3 Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1486-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-896-2015·2015-04-29

    Attix Pharmaceuticals Recalls Sirlolimus API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Sirlolimus active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Sirlolimus active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide