State

Illinois product recalls

72,971 recalls have nationwide distribution and so reach Illinois. 11,606 additional recalls listed Illinois specifically in their distribution scope.

What the numbers show

Total: 11,606
Critical: 2,039
Severe: 2,516
Most recent: 2026-09-16

Of the 11,606 recalls naming Illinois we have scored against our rubric, 2,039 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,516 (22%) are Severe.

Which agencies issued them

These figures cover only the 11,606 recalls whose distribution notice names Illinois specifically. The 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6126–6150 of 84577

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 (Devices)·Z-2280-2025·2025-08-20
Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.
Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0586-2025·2025-08-20
Sodium chloride injection containers recalled over potential fluid leakage at weld site
B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
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-0462-2025·2025-08-20
Cookies and cream paletas recalled because label lists cream without declaring milk
La Michoacana Cookies N Cream Single Serve Paletas, 3.75 oz, are recalled nationwide because the label names cream as an ingredient but does not declare milk as its source. 15,001 units are affected.
Product
La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0425-2025·2025-08-20
Dessert dip recalled nationwide after plastic foreign material found in product
Park Street Deli Cinnamon Bun Dessert Dip in 7 oz plastic tubs is recalled nationwide for plastic foreign material. 19,368 retail units are affected.
Product
Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in plastic tub UPC 4061462440151
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2287-2025·2025-08-20
Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output
Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.
Product
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0452-2025·2025-08-20
Tikka masala Indian curry sauce recalled over potential metal foreign objects
Sukhi's Tikka Masala Indian Curry Sauce, 3 oz, is recalled for potential contamination with metal pieces. The recall covers 4,869 pounds distributed across more than 25 states.
Product
Sukhi's, TIKKA MASALA INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00163-0, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER ROAD, HAYWARD, CA 94545 USA
Category
Food
Distribution
33 states
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-0459-2025·2025-08-20
La Michoacana strawberry paletas list cream without declaring milk as source
La Michoacana Strawberry Con Crema Single Serve Paletas are being recalled because the label includes the ingredient cream but does not include milk as the source. 62,864 units affected.
Product
La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2286-2025·2025-08-20
EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0582-2025·2025-08-20
Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level
Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.
Product
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: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0588-2025·2025-08-20
Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit
Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2297-2025·2025-08-20
3mensio workstation clock measurements may place stent graft fenestrations incorrectly
3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.
Product
3mensio Workstation (Vascular Fenestrated) software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0468-2025·2025-08-20
Mini variety paletas recalled because label lists cream without declaring milk
Helados Mexico Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 643,519 units are affected.
Product
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0464-2025·2025-08-20
Strawberry con crema paleta 6-packs recalled for cream without milk declaration
La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.
Product
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2025·2025-08-20
Thyroglobulin assay reagent recalled after lot generated erroneously high patient results
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
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 (Drugs)·D-0583-2025·2025-08-20
Theophylline extended-release tablets failed dissolution at long-term stability testing
Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.
Product
THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2292-2025·2025-08-20
Bartels Legionella urinary antigen kits may contain particulate matter
Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.
Product
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
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 (Food)·H-0443-2025·2025-08-20
Lithium orotate 2.5 mg product recalled for failing labeled potency specification
Lithium Orotate 2.5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency. The action follows a recall by the ingredient supplier.
Product
Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
Category
Food
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 (Devices)·Z-2289-2025·2025-08-20
Plastic trial heads carry inconsistent size terminology and color coding
Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.
Product
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0446-2025·2025-08-20
Lithium orotate 20 mg product recalled after failing labeled potency testing
Lithium Orotate 20 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, 20MG, Distributed by Enjoy Nutrition, LLC. UPC#: none
Category
Food
Distribution
Distributed nationwide