Safety Recalls

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15,259 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 5,151–5,200 of 15,259

Drug Recall · August 6, 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775,
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II
Medical Device Recall · August 6, 2025
Maquet Cardiovascular, LLC
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting ki
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Class II
Drug Recall · August 6, 2025
Westminster Pharmaceuticals LLC
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westm
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II
Drug Recall · August 6, 2025
Westminster Pharmaceuticals LLC
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westmi
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8 11836 02691 7 HI-TECH PHARMACEUTICALS, I
Unapproved Drug Claims and Misbranded.
Class III
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
Top Secret Nutrition extra strength uric control fast acting multi-pronged uric acid control 30 veggie caps DIETARY SUPPLEMENT UPC 8 11226 02158 4 Distributed by: TOP SECRET NUTRITION, LLC 6015-B Unit
Unapproved Drug Claims.
Class III
Medical Device Recall · August 6, 2025
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
The catheters may not retain their shape.
Class I
Food Recall · August 6, 2025
The Candy Barn
Chocolate Walnut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
Allergen labeling: specific tree nut (walnut) and egg are not listed in the 'contains' statement
Class II
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH FIGHTS OXIDATIVE STRESS 60 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02446 3 HI-TECH PHARMACEUTICALS,
Unapproved Drug Claims and Misbranded.
Class III
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS SUPPORTS TENDONS & MUSSCLES PROMOTES HEALTH CARTILAGE LUBRICATES JOINTS 240 Capsules UPC 7 97573 90884 1 6015-B Unity Drive Norcro
Unapproved Drug Claims.
Class III
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS NET WT. 8.12OZ (250g) DIETARY SUPPLEMENT
Unapproved Drug Claims and Misbranded.
Class III
Medical Device Recall · August 6, 2025
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
The catheters may not retain their shape.
Class I
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT PEACH MANGO NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPL
Unapproved Drug Claims and Misbranded.
Class III
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC.
Unapproved Drug Claims and Misbranded.
Class III
Medical Device Recall · August 6, 2025
ICU Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Class II
Food Recall · August 6, 2025
The Candy Barn
Grandma's Old-Fashioned Peanut Brittle, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, flexible plastic bag
Allergen labeling: missing allergens (peanuts, milk) in contains statement
Class II
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 0258
Unapproved Drug Claims.
Class III
Food Recall · August 6, 2025
The Candy Barn
Chocolate Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
Allergen labeling: egg is not listed in the 'contains' statement
Class II
Food Recall · August 6, 2025
Hi-Tech Pharmaceuticals Inc.
LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY SUPPLEMENT 17-PROANDRO pBOLD FORM-XT UPC 7 44890 94151 6 MADE FOR LG SCIENCES 6015-B UNITY DR. NORCROXX, GA
Unapproved Drug Claims.
Class III
Medical Device Recall · August 6, 2025
SEASPINE ORTHOPEDICS CORPORATION
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Class II
Medical Device Recall · August 6, 2025
ICU Medical Inc.
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product C
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Class II
Medical Device Recall · August 6, 2025
Olympus Corporation of the Americas
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The s
Potential for undetected, deformed a-traumatic tips.
Class I
Medical Device Recall · August 6, 2025
ICU Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Class II
Medical Device Recall · August 6, 2025
ICU Medical Inc.
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Class II
Medical Device Recall · August 5, 2025
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Ac
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Lepto
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252
Due to incomplete seals in the pouch which provide the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918
Due to incomplete seals in the pouch which provide the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Boston Scientific Corporation
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardi
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Class II
Medical Device Recall · August 5, 2025
Boston Scientific Corporation
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Class II
Medical Device Recall · August 5, 2025
Tandem Diabetes Care, Inc.
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Intero
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Class II
Medical Device Recall · August 5, 2025
Boston Scientific Corporation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Class II
Food Recall · August 5, 2025
Khee Trading, Inc.
Product is Frozen Half Shell Oysters in 15 pound blacks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER Spec: 144PCS; Imported by: Khee Trading Inc., Compton, CA Side
Imported Frozen Oyster potentially contaminated with Norovirus.
Class II
Food Recall · August 5, 2025
Kobayashi Noodle U.S.A.
Product is distributed in 10lb bulk packaging. Brown cardboard box with generic label. Raw Ramen Noodle HA #22W (4942) UPC: NONE Manufactured by: Kobayashi Noodle USA Allergens: Wheat, Egg
Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.
Class II
Drug Recall · August 5, 2025
Haleon US Holdings LLC
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK C
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class III
Medical Device Recall · August 5, 2025
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250
Due to incomplete seals in the pouch which provide the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM H
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Philips Medical Systems (Cleveland) Inc
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (0
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Class II
Vehicle Recall · August 5, 2025
Volvo Car USA, LLC
2024 VOLVO XC40, 2025 VOLVO EX40
A rearview camera image that does not display reduces the driver's view of what is behind the vehicle, increasing the risk of a crash.
Unclassified
Drug Recall · August 5, 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 0
Presence of foreign substance: identified as aluminum.
Class II
Food Recall · August 5, 2025
M.O.M Enterprises, LLC.
Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitamin C; LIQUID DIETARY SUPPLEMENT; AGE 4 MONTHS+, NET WT. 2 OZ (6
Potential for spoilage due to yeast contamination.
Class II
Medical Device Recall · August 5, 2025
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a m
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Boston Scientific Corporation
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Class II
Vehicle Recall · August 5, 2025
Chrysler (FCA US, LLC)
2023 CHRYSLER VOYAGER, 2023 CHRYSLER PACIFICA, 2024 CHRYSLER PACIFICA, 2025 CHRYSLER PACIFICA
An air bag with insufficient pressure retention increases the risk of ejection and injury during a crash.
Unclassified
Medical Device Recall · August 5, 2025
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist w
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356
Due to incomplete seals in the pouch which provide the sterile barrier.
Class II
Medical Device Recall · August 5, 2025
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393
Due to incomplete seals in the pouch which provide the sterile barrier.
Class II
Vehicle Recall · August 5, 2025
Chrysler (FCA US, LLC)
2025 RAM 3500
An inaccurate gear selection display may mislead the driver as to what gear is actually selected, leading to unexpected vehicle movement and increasing the risk of a crash.
Unclassified