Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

3726–3750 of 4878

SevereFDA (Food)·F-0971-2022·2022-04-13
Multiple Brands of Pineapple Spears and Chunks Recalled for Listeria Contamination
Fruit Fresh Up is recalling multiple pineapple products sold under various store brands due to potential Listeria monocytogenes contamination. Affected products were distributed in New York, Massachusetts, and Pennsylvania with best-by dates from March 5 to March 23, 2022.
Product
1. Wegmans 32oz Pineapple Spears 2. Fresh Harvest 18oz Pineapple Spears 3. Fresh Harvest 6# Pine Bucket 4. Tops Small Pineapple 5. Lexington Co-op 10oz Pineapple chunks 6. Lexington Co-op 32oz Pineapple Spears 7. EDU Kids 2 oz. Pineapple tidbits
Category
Food
Distribution
3 states
SevereFDA (Food)·F-0978-2022·2022-04-13
Fruit Fresh Up Recalls Bulk Fruit Salad for Potential Listeria Contamination
Fruit Fresh Up, Inc. is recalling Eden Valley Bulk Fruit Salad which may be contaminated with Listeria monocytogenes. The recall affects 39,232 units distributed in New York, Massachusetts, and Pennsylvania.
Product
Eden Valley Bulk Fruit Salad
Category
Food
Distribution
3 states
SevereFDA (Food)·F-0979-2022·2022-04-13
Tops Dill Dip Bulk recalled due to Listeria contamination risk
Tops Dill Dip Bulk is being recalled due to potential contamination with Listeria monocytogenes. Consumers should stop using the product and dispose of it safely.
Product
Tops Dill Dip Bulk
Category
Food
Distribution
3 states
SevereFDA (Food)·F-0981-2022·2022-04-13
Doodlebugs Tidbits Mix Recalled Due to Potential Listeria Contamination
Fruit Fresh Up, Inc. is recalling Doodlebugs Tidbits Mix (cantaloupe, honeydew, pineapple, watermelon) distributed in New York, Massachusetts, and Pennsylvania due to potential Listeria monocytogenes contamination.
Product
Doodlebugs 12 # Tidbits Mix (cantaloupe, honeydew, pineapple, watermelon )
Category
Food
Distribution
3 states
SevereFDA (Food)·F-0977-2022·2022-04-13
Fruit Fresh Up Raspberry Dip Recalled Due to Listeria Contamination Risk
Fruit Fresh Up, Inc. is recalling Fruit Fresh Up Raspberry Dip (7oz) due to potential Listeria monocytogenes contamination. Affected units distributed in NY, MA, and PA should not be consumed.
Product
Fruit Fresh Up Raspberry Dip (7oz)
Category
Food
Distribution
3 states
SevereFDA (Food)·F-0976-2022·2022-04-13
Lexington Co-op and EDU Kids Honeydew Products Recalled for Listeria
Fruit Fresh Up, Inc. recalls honeydew products that may contain Listeria monocytogenes. Affected products with best-by dates 03/05/2022–03/23/2022 were distributed in NY, MA, and PA.
Product
1. Lexington Co-op 10oz Honeydew Chunk (2/cs) 2. EDU Kids 2 oz Honeydew tidbits
Category
Food
Distribution
3 states
SevereFDA (Drugs)·D-0764-2022·2022-04-13
SYMJEPI Epinephrine Injection Recalled for Defective Delivery System Nationwide
Adamis Pharmaceuticals is recalling 2,500 cartons of SYMJEPI (epinephrine injection) nationwide due to a defective delivery system that may clog the needle and prevent medication dispensing.
Product
SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0973-2022·2022-04-13
Multiple cantaloupe products recalled due to potential Listeria contamination
Fruit Fresh Up, Inc. is recalling six cantaloupe products distributed in NY, MA, and PA (39,232 units) due to potential Listeria monocytogenes contamination. Products have best-by dates between March 5 and March 26, 2022.
Product
All BBD 03/05/22 through 03/23/2022 1. Wegmans 32oz Cantaloupe Spears 2. Fresh Harvest 18oz Cantaloupe Spears 3. Tops Large Cantaloupe 4. Tops Small Cantaloupe 5. Lexington Co-op 10oz Cantaloupe Chunk (4/cs) 6. EDU Kids 2 oz. Cantaloupe tidbits
Category
Food
Distribution
3 states
SevereFDA (Drugs)·D-0763-2022·2022-04-13
FDA Recalls SYMJEPI Epinephrine Injection for Potential Needle Clogging
Adamis Pharmaceuticals is recalling SYMJEPI epinephrine injections due to potential needle clogging that may prevent medication delivery. The FDA has classified this as a Class I recall affecting nationwide distribution.
Product
SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0972-2022·2022-04-13
Fruit Fresh Up melon trio and combo products recalled for Listeria contamination
Melon trio and combo products from Fruit Fresh Up may contain Listeria monocytogenes. Products distributed in NY, MA, and PA with best-by dates from March 5–23, 2022 are affected.
Product
1. Wegmans 32oz Melon Trio 2.Fresh Harvest 18oz Melon Trio 64779300400 3. Lexington Co-op 32oz Melon Trios 64779300403 4. Lexington Co-op 10oz Melon Combo 64779300370 5. Tops Large Mixed Melon 6. Tops Small Mixed Melon
Category
Food
Distribution
3 states
SevereFDA (Food)·F-0970-2022·2022-04-13
Watermelon Products Recalled Due to Potential Listeria Contamination
Fruit Fresh Up, Inc. recalled watermelon products from multiple retailers due to potential Listeria monocytogenes contamination. The recall affects 39,232 units distributed in NY, MA, and PA with best-by dates of March 5–23, 2022.
Product
1. Wegmans 10oz Watermelon Chunks 2. Wegmans 32oz Watermelon Chunks 3.Fresh Harvest 18oz Watermelon Chunks 4. Tops Large Watermelon BBD: 3/5/22 to BBD: 3/22/22 5. Tops Small Watermelon BBD: 3/5/22 to BBD: 3/22/22 6. Lexington Co-op 10oz Watermelon Chunks 7. Lexington Co-o
Category
Food
Distribution
3 states
SevereFDA (Food)·F-0964-2022·2022-04-13
Top Quality Produce Enoki Mushrooms Recalled for Listeria
Top Quality Produce Enoki Mushrooms are recalled due to Listeria monocytogenes contamination detected by California Department of Public Health. The recall affects 1108 cases distributed across six states.
Product
Top Quality Produce Enoki Mushrooms; 200G/7.05 oz. clear package with green bottom. Vacuumed packed Product of Taiwan. Keep Refrigerated, Cook before Eating. UPC: 848180019661 50 bags per box Distributed by: Top Quality Produce, Inc., Irwindale, CA 91706
Category
Food
Distribution
6 states
SevereNHTSA·21V979000·2022-04-12
2021-2022 Ford Mustang Mach-E and 2022 Maverick seat belt attachment recall
Ford is recalling 2021-2022 Mustang Mach-E and 2022 Maverick vehicles due to improperly attached rear seat belt buckles. The defect may prevent proper occupant restraint in a crash, creating an injury risk.
Product
FORD — 2021 FORD MUSTANG MACH E
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·20V521000·2022-04-08
Heartland Bighorn Traveler landing legs may collapse causing trailer to drop
Certain 2019-2021 Heartland Cyclone, 2020-2021 Bighorn Traveler, and 2020-2021 Elkridge recreational trailers may have insufficient bracing on the front landing legs, which could buckle and collapse while parked, causing the trailer to drop unexpectedly.
Product
HEARTLAND — 2020 HEARTLAND BIGHORN TRAVELER
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-0913-2022·2022-04-06
Taiwan Best Quality Enoki Mushrooms Recalled for Listeria monocytogenes Contamination
Jan Fruits, Inc. is recalling Taiwan Best Quality Enoki Mushrooms (UPC 8 51084 00835 8) due to detection of Listeria monocytogenes. The product was distributed in California.
Product
Taiwan Best Quality Enoki Mushrooms; 200g/7.05 oz. clear plastic bag (50 bags/pcs per box). Product is in a clear bag with green bottom. UPC 8 51084 00835 8. Product of Taiwan Manufacturer: Changhua County Mushrooms Production Cooperative.
Category
Food
Distribution
1 state
SevereFDA (Food)·F-0910-2022·2022-04-06
Yogurt-Covered Raisins Recalled Nationwide Due to Undeclared Peanuts
Multiple brands of yogurt-covered raisins distributed nationwide are being recalled due to undeclared peanuts. Consumers with peanut allergies face a serious health risk.
Product
Woody's Smokehouse brand Yogurt Raisins, 12.3 oz. (348g), clear plastic bag with front and back labels, UPC 0 95248 65531 0. Packed especially for Woody's Smokehouse Inc., Centerville, TX 75833, 903-536-9663, Woody's-Smokehouse.com Texas Best Smokehouse brand Yogurt Raisins, 8 o
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0912-2022·2022-04-06
St. Benoit Yogurt Recalled for Undeclared Egg Allergen
St. Benoit French Vanilla Yogurt is being recalled because it contains undeclared egg, a common allergen. Consumers with egg allergies should not consume the product.
Product
St. Benoit French Vanilla Yogurt; from pasture raised Jersey cows. Packaged in glass jar, net wt. 4.75 oz., UPC 6 49241 92910 9, St. Benoit Creamery. Sonoma, CA 95476 Certified Organic by CCOF
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0767-2022·2022-04-06
Meclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
Jubilant Cadista Pharmaceuticals recalls Meclizine Hydrochloride Tablets with incorrect labeling. Bottles labeled as PredniSONE contain Meclizine, risking medication errors.
Product
MECLIZINE HYDROCHLORIDE — MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE)
Category
Drug
Distribution
0 states
SevereFDA (Devices)·Z-0785-2022·2022-03-30
Philips Respironics respiratory ventilators recalled for foam degradation
Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.
Product
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0724-2022·2022-03-30
Sincalide Injection Recalled for Potency and Reconstitution Issues
Olympia Compounding Pharmacy is recalling Sincalide lyophilized powder for injection due to concerns about super potency and failed reconstitution time. The product is distributed nationwide, including Puerto Rico.
Product
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compou
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0750-2022·2022-03-30
Fresenius Kabi Sodium Acetate Injection Recalled for Particulate Matter
Fresenius Kabi USA is recalling sodium acetate injection due to the presence of particulate matter composed of carbon, oxygen, iron, and trace elements in multiple lots distributed nationwide.
Product
SODIUM ACETATE — SODIUM ACETATE (SODIUM ACETATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0907-2022·2022-03-30
Sprouts Dark Chocolate Covered Cherries Recalled for Undeclared Tree Nuts
Sprouts Farmers Market Dark Chocolate Covered Cherries may contain undeclared almonds. The FDA issued a Class I recall for this undeclared tree nut allergen.
Product
Sprouts Farmers Market Dark Chocolate Covered Cherries; Dried Cherries covered in Rich Dark Chocolate. Net Wt. 12 oz (340g) Item # 638-011 UPC: 6 46670 46342 6 Processed in a facility that processes on shared equipment with peanuts, tree nuts, wheat and milk. Distribu
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0740-2022·2022-03-30
Hand Sanitizer Isopropyl Alcohol Recall Due to Methanol Contamination
Tennessee Technical Coatings is recalling hand sanitizer products due to CGMP deviations. Certain lots were manufactured under the same conditions as a product lot found to contain methanol.
Product
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0668-2022·2022-03-30
Blaine Labs Revitaderm Wound Care Gel Recalled for Bacillus Contamination
The FDA has recalled Revitaderm Wound Care gel (Benzalkonium Chloride 0.1%) distributed nationwide due to contamination with Bacillus cereus. The affected product was distributed to 45 doctors in 17 states.
Product
REVITADERM WOUND CARE — REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0739-2022·2022-03-30
Hand Sanitizer Isopropyl Alcohol 75% Contaminated with Methanol
Tennessee Technical Coatings Corporation is recalling one lot of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% (1 U.S. Gallon) due to FDA analysis finding methanol contamination. The product was distributed in Alabama and Tennessee.
Product
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Category
Drug
Distribution
2 states