State

New Jersey product recalls

72,971 recalls have nationwide distribution and so reach New Jersey. 9,760 additional recalls listed New Jersey specifically in their distribution scope.

What the numbers show

Total: 9,760
Critical: 1,249
Severe: 2,483
Most recent: 2026-09-16

Of the 9,760 recalls naming New Jersey we have scored against our rubric, 1,249 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,483 (25%) are Severe.

Which agencies issued them

These figures cover only the 9,760 recalls whose distribution notice names New Jersey specifically. The 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6051–6075 of 82731

HighFDA (Devices)·Z-2283-2025·2025-08-20
Kittner gauze rolls had biological foreign matter and wrong pack quantity
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0585-2025·2025-08-20
Lactated Ringer's containers may leak at a weld site
Lactated Ringer's Injection USP in 1000 mL Excel containers is being recalled for lack of assurance of sterility because of the potential for fluid leakage at one of the weld sites. 74,088 containers affected.
Product
LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0580-2025·2025-08-20
Quallent duloxetine 60 mg capsules exceed the interim nitrosamine limit
Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 bottles affected.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
3 states
HighFDA (Food)·H-0470-2025·2025-08-20
Helados Mexico choco dipped paletas list cream without declaring milk
Helados Mexico Choco Dipped Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 70,044 units affected.
Product
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2025·2025-08-20
Kittner roll gauze with tail recalled over contamination and incorrect pack quantity
Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2025·2025-08-20
Custom waste management kit tubing may trap air in the line
Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.
Product
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2281-2025·2025-08-20
Kittner and tail gauze rolls had biological foreign matter inside packaging
Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0463-2025·2025-08-20
Coconut con crema 6-pack paletas recalled over undeclared milk in cream
La Michoacana Coconut Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 47,065 units are affected.
Product
La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2025·2025-08-20
High pressure tubing may separate and trap air in the line
High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.
Product
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0466-2025·2025-08-20
Variety paleta 16-count packs recalled over cream ingredient missing milk source
La Michoacana Variety Paletas, 16-count 44 oz packs, are recalled nationwide because the label lists cream but does not declare milk as its source. 2,241 units are affected.
Product
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0471-2025·2025-08-20
Choco-dipped mini paletas recalled because label lists cream but omits milk
Helados Mexico Choco-Dipped Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream without declaring milk as its source. 42,564 units are affected.
Product
Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0587-2025·2025-08-20
Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit
Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0449-2025·2025-08-20
Sukhi's classic curry paste may contain metal foreign objects
Sukhi's Classic Curry Paste in 2.5 lb packs is being recalled because of potential contamination with foreign objects, specifically metal pieces. 5,030 pounds are affected.
Product
Sukhi's CLASSIC CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-101, UPC: 7-67226-01001-4, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Category
Food
Distribution
33 states
HighFDA (Drugs)·D-0576-2025·2025-08-20
Amlodipine and olmesartan tablets recalled after failing dissolution specification testing
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.
Product
AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0460-2025·2025-08-20
Mango con crema paletas recalled for listing cream without milk allergen declaration
La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.
Product
La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0579-2025·2025-08-20
Glenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level
Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2025·2025-08-20
FARAWAVE ablation catheters may have cracks in the distal electrode bands
FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.
Product
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2321-2025·2025-08-20
Medication dispensing cabinets recalled after reports of delayed access during override workflow
BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.
Product
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0444-2025·2025-08-20
Lithium orotate 5 mg product recalled after failing to meet labeled potency
Lithium Orotate 5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide for failing to meet its labeled potency, following a recall by the ingredient supplier.
Product
Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730893968, 702730894064
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2323-2025·2025-08-20
Heparin control material recalled after quality control results fell below acceptance range
HemosIL LMW Heparin Controls, part number 0020300200, are recalled after complaints of lower than expected quality control recovery. 41,824 units are affected.
Product
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2298-2025·2025-08-20
Ultra IABP catheter kits carry indications not reviewed by the FDA
Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.
Product
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available wi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2288-2025·2025-08-20
Prosthesis heads carry inconsistent size terminology and color coding on labeling
Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.
Product
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2324-2025·2025-08-20
Anorectal manometry kit outer label shows the manufacturing date as expiry
Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.
Product
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0442-2025·2025-08-20
Lithium orotate 1 mg product recalled for failing labeled potency requirement
Lithium Orotate 1 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Product
Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. UPC#: 717340952714
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0445-2025·2025-08-20
Lithium orotate 10 mg product recalled for failing labeled potency standard
Lithium Orotate 10 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Product
Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730894033, 702730894057
Category
Food
Distribution
Distributed nationwide