Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

10051–10075 of 27638

SevereFDA (Devices)·Z-0227-2025·2024-11-13
Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination
Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.
Product
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
Category
Medical Device
Distribution
11 states
SevereFDA (Food)·F-0102-2025·2024-11-13
Aunt Millie's Whole Grain Dinner Rolls Recalled for Undeclared Sesame
Perfection Bakeries LLC is recalling 1,144 cases of Aunt Millie's Bakehouse Whole Grain Dinner Rolls due to undeclared sesame. The product was distributed in 12 states. Consumers with sesame allergies should not consume this product.
Product
Aunt Millie s Bakehouse Whole Grain Dinner Rolls 2.5" Sliced 1.34 OUNCE. 8 unlabeled 24CT PKGS per sale unit case, product code 7488. Net. Wt. 16lbs.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0099-2025·2024-11-13
Aunt Millie's Bakehouse Hawaiian Hamburger Buns Recalled for Undeclared Sesame
Aunt Millie's Bakehouse Hawaiian Hamburger Buns contain undeclared sesame and are being recalled by Perfection Bakeries LLC. The Class I recall affects 6,400 cases distributed across 12 states.
Product
Aunt Millie s Bakehouse Hawaiian Hamburger Buns 4.5" Sliced 3 OUNCE. 6 unlabeled 12CT PKGS per sale unit case, product code 7430. Net Wt. 13lb 8oz.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0101-2025·2024-11-13
Bread Recall: Undeclared Sesame Allergen in Aunt Millie's Bakehouse
Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse 100% Whole Wheat Pullman Bread due to undeclared sesame. Affected product was distributed across twelve U.S. states.
Product
Aunt Millie s Bakehouse 100% Whole Wheat Pullman Bread 1/2" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9520, Net Wt. 16lbs. 8oz.
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0040-2025·2024-11-13
Ascorbic Acid Injection Recalled Nationwide for Glass Contamination
Staska Pharmaceuticals recalled ascorbic acid injectable solution due to glass contamination. The FDA classified the recall as Class I; 4,773 vials nationwide were affected.
Product
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0107-2025·2024-11-13
MyChai Chai Tea Concentrate recalled for improper pH and missing production records
My Chai Inc is recalling MyChai Chai Tea Concentrate KALI nationwide because pH levels were found above 4.1 and production records are missing. Consumers should not consume the product.
Product
MyChai Chai Tea Concentrate KALI, 68 fl. oz. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is induction sealed during the bottling process. Shelf stable 3 year expiration from date of manufacture Ingredients: Water, Sugar, Organic Black Tea Ex
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0122-2025·2024-11-13
Kirkland Signature Butter Recalled for Missing Milk Allergen Statement
Kirkland Signature Salted Sweet Cream Butter is being recalled because the packaging may lack the required 'Contains Milk' allergen warning. Consumers with milk allergies who purchased this product in Texas should not consume it.
Product
Kirkland Signature Salted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38488.
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0039-2025·2024-11-13
FDA Recalls Regadenoson Injection for Missing Label Information
Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection nationwide due to missing label information on affected lot numbers. Healthcare providers with affected lots should contact the manufacturer for replacement supplies.
Product
REGADENOSON — REGADENOSON (REGADENOSON)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2025·2024-11-13
Surgical neurological sponges recalled for detaching X-ray markers
American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.
Product
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
Category
Medical Device
Distribution
8 states
HighFDA (Drugs)·D-0037-2025·2024-11-13
Morphine Sulfate Extended-Release Tablets Recalled for Failed Impurities Specification
Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 30 mg (Lot FG13996) nationwide due to failed impurities and degradation specifications.
Product
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0324-2025·2024-11-13
Hillrom Diagnostic Cardiology Suite Software Duplicate UID Assignment Recall
Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.
Product
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0325-2025·2024-11-13
Cardiac stress testing system may assign duplicate exam identifiers to patients
Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.
Product
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0097-2025·2024-11-13
EM Tortillas Mexican sweet bread recalled for undeclared allergens
EM Tortillas, LLC is recalling bulk Mexican sweet bread varieties due to undeclared wheat, soy, and egg allergens. Products are packaged in unlabeled poly bags and distributed in California.
Product
Bulk Mexican sweet bread varieties including conchas, fino ellotes, fino curenos, danes ellotes, danes cuernos, bolillos, and teleras. Bakery products are packaged in unlabeled poly bags.
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0036-2025·2024-11-13
Morphine Sulfate Extended-Release Tablets Recalled for Impurities and Degradation
Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 15 mg nationwide due to failed impurity and degradation specifications. Patients taking affected lots should contact their healthcare provider immediately.
Product
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0308-2025·2024-11-13
DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.
Product
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2025·2024-11-13
Electrocardiograph System May Assign Duplicate Identifiers to Patient Exams
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.
Product
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0098-2025·2024-11-13
Hammond's Dark Chocolate Waffle Cones Recalled for Undeclared Milk Allergen
Hammond's Candies is recalling Dark Chocolate Filled Mini Waffle Cones nationwide due to undeclared milk allergen. Consumers with milk allergies should not consume this product.
Product
Hammond's Dark Chocolate Filled Mini Waffle Cones, packaged in a 4 oz (113g) Stand-Up Resealable Pouch. Item Number: FC23212; UPC 6 91355 90513 5. Label declares ***CONTAINS: WHEAT, SOY, TREE NUTS (COCONUT)***PACKAGED IN A FACILITY THAT PROCESSES EGG, MILK, MUSTARD, PEANUTS, SE
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0041-2025·2024-11-13
Generic Ibuprofen 800mg Recalled Due to Failed Impurity and Degradation Specifications
Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.
Product
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 cou
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0320-2025·2024-11-13
Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0307-2025·2024-11-13
DeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction
DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.
Product
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0319-2025·2024-11-13
Coated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.
Product
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0286-2025·2024-11-13
epoc BGEM BUN Test Cards recalled for sodium measurement bias
Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events reported.
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0318-2025·2024-11-13
GE Healthcare Centricity Viewer Security Vulnerability Could Allow Unauthorized Access
GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.
Product
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centric
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2025·2024-11-13
DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled
DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.
Product
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0035-2025·2024-11-13
Timolol Maleate Eye Drops Recalled Due to Defective Container
FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.
Product
TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
Category
Drug
Distribution
1 state

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10051–10075 of 27638