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.

9051–9075 of 22113

HighFDA (Devices)·Z-0599-2025·2024-12-11
Atellica CH β2-Microglobulin Reagent Produces Falsely Depressed Results
Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.
Product
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0234-2025·2024-12-11
Sysco Classic Strawberry Drink Mix recalled for metal fragment contamination
Sysco Classic Strawberry Drink Mix is being recalled due to metal fragments discovered during production. A damaged sifter in dextrose processing introduced the contamination into the product.
Product
Sysco Classic Strawberry Drink Mix Artificial Flavor, NET WT. 24OZ (1 LB 8 OZ) 690g, UPC 0 74865 09328 6, Case UPC 10074865093283, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
Category
Food
Distribution
30 states
HighFDA (Drugs)·D-0076-2025·2024-12-11
Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0089-2025·2024-12-11
Array Liquid Antiseptic Handwash Recalled for Microbiological Test Failures
Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.
Product
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2025·2024-12-11
Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation
The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.
Product
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0619-2025·2024-12-11
Medline MaxOrb Extra Alginate Wound Dressing Recalled for Packaging Defect
Advanced Medical Solutions is recalling 1,800 boxes of Medline MaxOrb Extra Alginate Wound Dressing due to defects in the primary packaging pouch that compromise sterile barrier integrity. Products affected were distributed in Illinois, Texas, and Virginia.
Product
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0615-2025·2024-12-11
GE Healthcare CT Operator Console Update: Images May Rotate Progressively
GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.
Product
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0596-2025·2024-12-11
Medical Device Breach: BACTEC 9240 System Faces Unauthorized Access Risk
Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.
Product
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0105-2025·2024-12-11
Duloxetine Delayed-Release Capsules Nationwide Recall for N-Nitroso Impurity
Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0574-2025·2024-12-11
X-ray system hand switch may fail under mechanical stress
The Ziehm Solo FD interventional fluoroscopic x-ray system's hand switch may fail when exposed to mechanical stress, potentially causing unintended radiation. Twenty-five units are affected in the U.S. and Puerto Rico.
Product
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0253-2025·2024-12-11
Traditional Country Canning spaghetti sauce recalled for undeclared egg allergen
Englewood Cannery is recalling Traditional Country Canning Spaghetti Sauce (16 oz.) because it contains undeclared egg, a common allergen. The affected product was distributed in Alabama and Tennessee.
Product
Traditional Country Canning Spaghetti Sauce, Net Wt. 16 oz. (453g), packaged in glass jars with metal lids, 12 jars per case
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0097-2025·2024-12-11
Diltiazem extended-release capsules recalled for manufacturing impurity
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0077-2025·2024-12-11
FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0232-2025·2024-12-11
Sysco Classic Lemonade Drink Mix recalled for metal fragments
Sysco Classic Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. Consumers should not consume the product and should discard it or return it to their retailer.
Product
Sysco Classic Lemonade Drink Mix Natural Flavor, NET WT. 24OZ (1 LB 8 OZ) 690g, UPC 0 74865 09325 5, Case UPC 10074865093252, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077ON, HOUSTON, TEXAS 77077
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0578-2025·2024-12-11
Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation
Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.
Product
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0241-2025·2024-12-11
Thirster Low Cal Fruit Recalled for Metal Fragment Contamination
Dyma Brands recalls Thirster Low Cal Fruit due to metal fragments in the product from a damaged sifter during dextrose production. The affected pouches were distributed across 29 states.
Product
THIRSTER LOW CAL FRUIT, NET WT. 8.6OZ, Case UPC 50758108397380, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
Category
Food
Distribution
30 states
HighFDA (Drugs)·D-0090-2025·2024-12-11
ROYALAB Germ Away Antibacterial Hand Soap Recalled for Failed Microbiological Testing
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
Product
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0096-2025·2024-12-11
Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0222-2025·2024-12-11
AROMA VITA Hot Cocoa Mix Recalled for Metal Fragments
AROMA VITA Hot Cocoa Mix is being recalled due to metal fragments in the product caused by a damaged sifter used during dextrose production.
Product
AROMA VITA HOT COCOA MIX, NET WT. 32OZ (2LBS) 907g, UPC 7 1908 50007 0, Case UPC 50719098500075, Distributed by DYMA Brands, Inc. Atlanta, GA 30328
Category
Food
Distribution
30 states
HighFDA (Drugs)·D-0108-2025·2024-12-11
Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
Product
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0595-2025·2024-12-11
BACTEC 9120 System Recalled Due to Compromised Service Credentials
BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.
Product
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0109-2025·2024-12-11
Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
Product
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0080-2025·2024-12-11
Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination
American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.
Product
VENOFER — VENOFER (IRON SUCROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0247-2025·2024-12-11
Ready-meal chicken tacos recalled due to Listeria monocytogenes
Albertsons ready-meal chicken street taco kits have been recalled due to potential Listeria monocytogenes contamination in the cooked chicken. The recall affects 2,374 units distributed across 21 U.S. states.
Product
(1) READY MEALS CHICKEN STREET TACOS SS COLD (UPC 27131600000) (2) READY MEALS ASADA STREET TACO MEAL SS COLD (UPC 29939100000) (3) READY MEALS CHICKEN STREET TACO MEAL SM SS COLD (UPC 27179600000)
Category
Food
Distribution
21 states
HighFDA (Devices)·Z-0612-2025·2024-12-11
GE Healthcare CT systems produce progressively rotated images in scan modes
Certain GE Healthcare CT systems can produce progressively rotated images during helical and cardiac scans. Images may rotate up to 56 degrees, potentially affecting diagnosis if the rotation is not detected.
Product
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states