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.

9076–9100 of 22113

HighFDA (Drugs)·D-0106-2025·2024-12-11
Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits
Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Category
Drug
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-0582-2025·2024-12-11
Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect
Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.
Product
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0649-2025·2024-12-11
Medline recalls surgical kits containing Stryker smoke evacuation pencil component
Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0600-2025·2024-12-11
GE Healthcare CT Systems May Display Rotated Images in Diagnostic Scans
Certain GE Healthcare CT systems may produce progressively rotated images during diagnostic scans. If undetected and a rescan is needed, the same rotation recurs.
Product
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0226-2025·2024-12-11
Gordon CHOICE Lemonade Mix Recalled for Metal Fragment Contamination
Gordon CHOICE Lemonade Beverage Mix is being recalled for metal fragment contamination in the product. Consumers should stop using affected packages and contact the manufacturer.
Product
Gordon CHOICE Lemonade Beverage Mix Naturally Flavored Low Calorie Instant LOW CAL LEMONADE, NET WT. 8.6 OZ (243 g), UPC 0 93901 59605 5, Case UPC 10093901596052, FOR DISTRIBUTION EXCLUSIVELY BY PARA SU DISTRIBUCION EXCLUSIVA POR GORDON FOOD SERVICE WYOMING, MI 49509
Category
Food
Distribution
30 states
HighFDA (Food)·F-0233-2025·2024-12-11
Sysco Pink Lemonade Drink Mix Recalled for Metal Fragment Contamination
Sysco Classic Pink Lemonade Drink Mix is recalled because a damaged sifter during production introduced metal fragments into the product. Products were distributed across 29 states.
Product
Sysco Classic Pink Lemonade Drink Mix Natural Flavor, NET WT. 24OZ(1 LB 8 OZ) 680 g, UPC 0 74865 09326 2, Case UPC 10074865093269, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
Category
Food
Distribution
30 states
HighFDA (Drugs)·D-0098-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0240-2025·2024-12-11
THIRSTER Lemonade Drink Mix Recalled for Metal Fragment Contamination
DYMA Brands recalls THIRSTER Lemonade Drink Mix because a damaged sifter used in dextrose production introduced metal fragments into the product. The product was distributed to 29 states.
Product
THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE, NET WT. 8.6 OZ (244 g), UPC 7 58108 39736 4, Case UPC 50758108397359, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
Category
Food
Distribution
30 states
HighFDA (Food)·F-0231-2025·2024-12-11
Sysco Fruit Punch Drink Mix recalled for metal fragments
Sysco Classic Fruit Punch Drink Mix is being recalled due to metal fragments introduced by a damaged sifter during manufacturing. The affected product (Case UPC 00734730132709, Lot 263 EFA) was distributed across 29 states.
Product
Sysco Classic Fruit Punch Drink Mix Natural and Artificial Flavor, NET WT. 8.6OZ (244 G), Case UPC 00734730132709, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0592-2025·2024-12-11
BD Phoenix M50 Automated Microbiology System Service Credentials Exposed
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.
Product
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0223-2025·2024-12-11
Vanilla Instant Pudding Mix Recalled for Contamination with Metal Fragments
DYMA Brands is recalling Culinary Secrest Originals Vanilla Instant Pudding Mix because a damaged sifter introduced metal fragments into the product. Consumers should not consume the product.
Product
CULINARY SECREST ORIGINALS VANILLA INSTANT PUDDING MIX NATURAL & ARTIFICIAL FLAVOR, NET WT. 24 OZ. (1.5 LB.) 680g, 8 UPC 22486 19071 2, Case UPC 30822486190706 and NET WT. 28 OZ. (1.75 LB.) 793g, UPC 8 22486 19070 5, Case UPC 30822486190706, MARKETED BY INDEPENDENT MARKETING ALLI
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0618-2025·2024-12-11
McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect
McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.
Product
McKesson Calcium Alginate Dressing MFR# 3562 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-0643-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0243-2025·2024-12-11
Member's Mark Roasted Red Pepper Hummus Recalled for Potential Foreign Objects
Cedar's Mediterranean Foods is recalling Member's Mark Roasted Red Pepper Hummus due to potential presence of foreign objects. The recall affects 23,136 units distributed to retail locations in ten states.
Product
Member's Mark brand Roasted Red Pepper Hummus; 32 oz (907 g) Plastic Container with UPC# 193968044268
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-0620-2025·2024-12-11
Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0626-2025·2024-12-11
Medline recalls surgical convenience kits with defective smoke evacuation component
Medline is recalling five types of medical convenience kits because they contain the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled.
Product
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0585-2025·2024-12-11
BD EpiCenter Data Management System Credential Compromise Poses Unauthorized Access Risk
Service credentials for the BD EpiCenter Data Management System were accessed by an unauthorized actor. Until credentials are updated, system data and access controls are at risk.
Product
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0099-2025·2024-12-11
Duloxetine Delayed-Release Capsules Recalled Due to Manufacturing Quality Deviation
Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.
Product
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
Category
Drug
Distribution
3 states
HighFDA (Food)·F-0250-2025·2024-12-11
Cinnamon Apple Cider Recalled for Elevated Patulin Contamination
Apple Wedge Cinnamon Apple Cider is being recalled due to elevated patulin contamination detected in testing. Affected products were distributed to Georgia, North Carolina, South Carolina, and Florida.
Product
Cinnamon Pasteurized APPLE WEDGE CIDER 1/2 Gal. (1.89L) HENDERSONVILLE, NC 28792 Keep Refrigerated Produce of USA Ingredients: Apples, Natural Cinnamon Flavor. 0.1% Potassium Sorbate Added as Preservative UPC 0 36482 64002 1
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-0593-2025·2024-12-11
BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk
BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.
Product
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2025·2024-12-11
MEDLINE dental and oral surgery kits recalled due to defective component
MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Category
Medical Device
Distribution
Distributed nationwide
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 (Devices)·Z-0601-2025·2024-12-11
GE Healthcare Optima 520 CT systems recalled for image rotation
GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.
Product
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0640-2025·2024-12-11
MEDLINE convenience kits recalled due to defective component
Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
Category
Medical Device
Distribution
Distributed nationwide