The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

11301–11325 of 29159

  • SevereFDA (Food)·F-2163-2019·2019-09-25

    Harris Teeter Garlic Hummus Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling Harris Teeter Fresh Foods Market Garlic Hummus due to potential Listeria monocytogenes contamination.

    Product
    Harris Teeter Fresh Foods Market Garlic Hummus 10 oz. UPC 072036027023 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1860-2019·2019-09-25

    Soothing Sore Relief Lidocaine Cream Recalled for High Potency

    Ridge Properties, LLC is recalling Soothing Sore Relief (lidocaine) Cream, 4%, because the product was found to be contaminated and above specification for lidocaine assay.

    Product
    Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1866-2019·2019-09-25

    Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 3,240 cartons of Allergy Relief (fexofenadine hydrochloride) tablets because they failed impurity and degradation specifications.

    Product
    Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1874-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 4,536 cartons of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2202-2019·2019-09-25

    PitaPal Organic Hummus Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling PitaPal Organic Original Hummus due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    PitaPal Organic Original Hummus 10 oz. and 17 oz. UPC 851570003317 and UPC 851570003058 packaged in Plastic tub with clear lid with green rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2228-2019·2019-09-25

    Pita Pal Foods Recalls 7-Select Chipotle Garlic Hummus Due to Listeria Risk

    Pita Pal Foods LP is recalling 7-Select Chipotle Garlic Hummus w/ Pretzels because the product has the potential to be contaminated with Listeria monocytogenes.

    Product
    7-Select Chipotle Garlic Hummus w/ Pretzels 4.1 oz. UPC 52548595289 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1873-2019·2019-09-25

    Aurolife Pharma Recalls Wal-Fex Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 4,920 cartons of Wal-Fex (Fexofenadine Hydrochloride) 180 mg tablets nationwide because they failed impurity and degradation specifications.

    Product
    Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2218-2019·2019-09-25

    Reasor's Hummus Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling Reasor's Original Hummus with Pretzel due to potential Listeria monocytogenes contamination.

    Product
    Reasor's Original Hummus with Pretzel 4.1 oz UPC 78767 00079 packaged in Plastic tub with clear lid with black rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1861-2019·2019-09-25

    FDA Recalls Soothing Sore Relief Lidocaine Gel Due to Contamination

    Ridge Properties, LLC is recalling Soothing Sore Relief (lidocaine) Liquid Gel, 4%, because the product was found to be contaminated and above specification for lidocaine assay.

    Product
    Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2219-2019·2019-09-25

    Pita Pal Recalls Reasor's Hummus with Pretzel Due to Listeria Risk

    Pita Pal Foods LP is recalling Reasor's Original Hummus with Pretzel due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Reasor's Original Hummus with Pretzel 4.1 oz UPC 78767 00079 packaged in Plastic tub with clear lid with black rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2242-2019·2019-09-25

    Weston Foods Recalls Pumpkin Cake Rolls Due to Metal Contamination

    Weston Foods (Canada) Inc. is recalling specific lots of Pumpkin Cake Rolls and Pumpkin Junior Cake Rolls because they contain lead and other metal pieces.

    Product
    Pumpkin Cake Roll - Pumpkin Spice Cake Roll with Creme Filling - Naturally Flavored - 1 CAKE ROLL - NET WT. 18 OZ (1 LB 2 OZ) 510 g; Pumpkin Junior Cake Rolls or Pumpkin Swiss Roll - Pumpkin Spice Cake Roll with Creme filling - Naturally Flavored - 6 CAKE ROLLS - NET WT. 14 OZ…
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·19V678000·2019-09-25

    BMW Recalls 2020 X3 and X4 Models for Front Axle Bearing Defect

    BMW is recalling 2020 X3 and X4 vehicles because improperly heat-treated front axle swivel bearings may break, causing loss of vehicle control.

    Product
    BMW — BMW X4, X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1864-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 8,240 bottles of Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2179-2019·2019-09-25

    Lantana Roasted Garlic Hummus Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling Lantana Roasted Garlic Hummus due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Lantana Roasted Garlic Hummus 2 pack of 10 oz. and 10 oz. UPC 10855432004143 and 20896863001421 packaged in Shrink wrapped plastic tubs with multi-colored lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2160-2019·2019-09-25

    Bucee's Garlic Hummus Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling Bucee's Garlic Hummus with Pretzels due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bucee's Garlic Hummus with Pretzels 4.1 oz UPC 850157000312 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1858-2019·2019-09-25

    Superior Pain & Itch Relief Cream Recalled for Lidocaine Contamination

    Ridge Properties, LLC is recalling Superior Pain & Itch Relief Cream because the product was found to be contaminated and above specification for lidocaine assay.

    Product
    Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 69804-070-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2164-2019·2019-09-25

    Harris Teeter Olive Hummus Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling Harris Teeter Fresh Foods Market Olive Hummus due to potential Listeria monocytogenes contamination.

    Product
    Harris Teeter Fresh Foods Market Olive Hummus 10 oz. UPC 072036952066 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2167-2019·2019-09-25

    Harris Teeter Spicy Hummus Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling Harris Teeter Fresh Foods Market Spicy Hummus due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Harris Teeter Fresh Foods Market Spicy Hummus 10 oz. UPC 072036950444 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2161-2019·2019-09-25

    Pita Pal Recalls Bucee's Texas Spicy Hummus Due to Listeria Risk

    Pita Pal Foods LP is recalling Bucee's Texas Spicy Hummus w/ Pretzels due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bucee's Texas Spicy Hummus w/ Pretzels 4.1 oz. UPC 850157003023 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2207-2019·2019-09-25

    PitaPal Garden Vegetable Hummus Recalled for Listeria Contamination Risk

    Pita Pal Foods LP is recalling 11 cases of Garden Vegetable Hummus due to potential Listeria monocytogenes contamination.

    Product
    PitaPal Garden Vegetable Hummus 5 lbs UPC 851351007879 packaged in White plastic tub with white lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2229-2019·2019-09-25

    Pita Pal Recalls 7-Select Hummus for Potential Listeria Contamination

    Pita Pal Foods LP is recalling 7-Select Classic Hummus w/ Pretzel due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    7-Select Classic Hummus w/ Pretzel 4.1 oz. UPC 52548595272 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0002-2020·2019-09-25

    Hiland Dairy Lemonade Recalled for Undeclared Milk Allergen

    Hiland Dairy Foods is recalling 928 units of lemonade in Oklahoma, Kansas, and Missouri due to undeclared milk.

    Product
    One-Half Gallon Hiland Dairy Lemonade UPC: 72060-00519-6 packaged in plastic bottle and Pint Hiland Dairy Lemonade UPC: 72060-00524-0 packaged in plastic bottle
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1868-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling specific lots of Fexofenadine Hydrochloride 180 mg tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1856-2019·2019-09-25

    PRE-TAT Lidocaine Cream Recalled for Microbial Contamination and Assay Failures

    Ridge Properties, LLC is recalling PRE-TAT Lidocaine Cream due to microbial contamination and lidocaine assay levels above specification. The product was sold nationwide via online retailers.

    Product
    PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1871-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine HCL Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 6,104 bottles of Fexofenadine HCL 180 mg tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
    Category
    Drug
    Distribution
    Distributed nationwide