The Recall Desk

State

Indiana product recalls

72,969 recalls have nationwide distribution and so reach Indiana. 9,556 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,556
Critical
1,903
Severe
2,136
Most recent
2026-09-16

Of the 9,556 recalls naming Indiana we have scored against our rubric, 1,903 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,136 (22%) are Severe.

These figures cover only the 9,556 recalls whose distribution notice names Indiana specifically. The 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6451–6475 of 82525

  • SevereFDA (Drugs)·D-0490-2025·2025-07-02

    Fresenius Sodium Chloride Injection Recall: Lack of Sterility Assurance

    Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection in flexible plastic containers nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0494-2025·2025-07-02

    Ketorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk

    Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% due to lack of assurance of sterility. The recall affects 87,840 bottles distributed nationwide.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0476-2025·2025-07-02

    LL Bioboost Injectable pre-filled syringes recalled for lack of sterility assurance

    Thrive Health and Wellness, LLC is recalling LL Bioboost Injectable pre-filled syringes nationwide due to lack of assurance of sterility. The affected product is Lot #H277639 with expiration 6/25/2025.

    Product
    LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V447000·2025-07-02

    Blue ARC BA4L-800 Recalled for Parking Brake Defect

    Shyft Group is recalling 2024-2025 Blue ARC BA4L-800 vehicles because a brake caliper spacer may be too big, preventing the parking brake from engaging properly.

    Product
    BLUE ARC — BLUE ARC BA4L-800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0063-2025·2025-07-02

    Shore Lunch Breading and Batter Mix Recalled for Undeclared Milk

    Homegrown Family Foods LLC is recalling Shore Lunch Breading & Batter Mix Oven Style because it contains undeclared milk, a common allergen. The product was distributed across multiple Midwestern and East Coast states.

    Product
    Shore Lunch BREADING & BATTER MIX OVEN STYLE A savory, crunchy coating perfect for fish, pork and chicken. Net Wt 6oz (170g) UPC 0 24739 12000 6 Summit Hill Foods Rome, GA 30162
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1959-2025·2025-07-02

    Extended Tip Applicator 15 CM recalled for endotoxin and sterility issues

    Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.

    Product
    Extended Tip Applicator, 15 CM, Box of 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1958-2025·2025-07-02

    Extended Tip Applicator 8CM distributed by Integra LifeSciences recalled nationwide

    Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.

    Product
    Extended Tip Applicator, 8CM, Box of 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0495-2025·2025-07-02

    Azelastine Hydrochloride Ophthalmic Solution Recalled Due to Sterility

    Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% due to lack of assurance of sterility. The affected batch was distributed nationwide.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0474-2025·2025-07-02

    Methylcobalamin Injectable Pre-filled Syringe Recalled for Sterility Concerns

    Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0485-2025·2025-07-02

    Tirzepatide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance

    Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin Injectable 15mg/1mg/mL pre-filled syringes (Lot C03065F) due to lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2025·2025-07-02

    NAD+ Pre-Filled Syringes Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot #O-O8A01-25) distributed nationwide due to lack of assurance of sterility. Consumers should not use this product.

    Product
    Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0482-2025·2025-07-02

    Tirzepatide Injections Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling Tirzepatide Injections (10mg/mL, pre-filled syringes) distributed nationwide due to lack of assurance of sterility. Consumers should not use the affected product and contact their healthcare provider.

    Product
    Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0487-2025·2025-07-02

    NAD+ Injectable Solution Recalled Due to Lack of Sterility Assurance

    Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot GA37484) because the manufacturer cannot assure the product is sterile. The product was distributed nationwide.

    Product
    Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction failure recall

    Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (REF 381423, 22GA X 1.00 IN) due to the possibility that the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2025·2025-07-02

    BD Pyxis Dispensing Cabinet Software Configuration Error Medical Device Recall

    CareFusion is recalling BD Pyxis automated dispensing cabinets and related devices due to a software configuration issue that can prevent user access to the medication dispensing application. This may delay patient care when Microsoft patches are installed during system upgrades.

    Product
    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw labeling mismatch recall

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling indicates a different screw size than the product actually included. This mismatch could lead to incorrect surgical implantation.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2004-2025·2025-07-02

    BD Insyte Autoguard BC Pro Winged Shielded IV Catheter Needle Retraction Issue

    Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (18 GA x 1.16 in, Lot 4208538) due to reports that the catheter needle may be slow to retract or fail to retract completely.

    Product
    REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1996-2025·2025-07-02

    DxI 9000 Access Immunoassay Analyzer calibration system error recall

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous test results.

    Product
    DxI 9000 Access Immunoassay Analyzer C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2025·2025-07-02

    BD Insyte Autoguard Winged IV Catheter needle retraction failure recall

    Becton Dickinson is recalling BD Insyte Autoguard Winged IV Catheters (Ref. 381533, Lot 4282452) because the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V409000·2025-07-02

    Polestar 2 May Lose Brake Function While Using One Pedal Drive

    Certain 2021 and 2024 Polestar 2 vehicles may lose brake function while coasting downhill and using One Pedal Drive mode. Polestar will provide a free over-the-air software update to fix the control module defect.

    Product
    POLESTAR — POLESTAR POLESTAR 2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2025·2025-07-02

    Barco NexxisOR System Display Encoders and Decoders Recalled

    Barco N.V. is recalling certain NexxisOR system display encoder and decoder models due to duplicate MAC addresses that can cause system malfunction, audio/video interruptions, and delayed procedures when multiple units are deployed together.

    Product
    Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction defect

    Becton Dickinson is recalling one lot of BD Insyte Autoguard Shielded IV Catheters (REF 381433, 20GA x 1.00 in) due to reports that the catheter needle may retract slowly or fail to retract completely.

    Product
    REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2025·2025-07-02

    BD Insyte Autoguard BC Pro IV Catheter Needle Retraction Defect

    Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (REF 382944) due to reports that the catheter needle may retract slowly or fail to retract completely.

    Product
    REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2025·2025-07-02

    BD Insyte Autoguard BC Winged IV Catheter Needle Retraction Issue

    Becton Dickinson is recalling a specific lot of BD Insyte Autoguard BC Winged IV catheters (REF 382633, Lot 4222721) due to reports that the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2025·2025-07-02

    Bigfoot Unity Diabetes Management System Pen Caps Unresponsive Due to Firmware Error

    Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.

    Product
    Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
    Category
    Medical Device
    Distribution
    Distributed nationwide