State

Indiana product recalls

73,495 recalls have nationwide distribution and so reach Indiana. 9,589 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total: 9,589
Critical: 1,913
Severe: 2,528
Most recent: 2026-10-14

Of the 9,589 recalls naming Indiana we have scored against our rubric, 1,913 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,528 (26%) are Severe.

Which agencies issued them

These figures cover only the 9,589 recalls whose distribution notice names Indiana specifically. The 73,495 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

24526–24550 of 83084

HighFDA (Devices)·Z-0500-2022·2022-01-26
ImagePilot diagnostic imaging software versions 1.92 and 1.93 measurement error recall
Konica Minolta's ImagePilot versions 1.92 and 1.93 software may provide incorrect measurement calculations if improper power sequences are used with AeroDR or Momentum Panel systems.
Product
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2022·2022-01-26
Voyager Rollator Walkers Recalled for Wheel Separation and Fall Risk
Compass Health Brands is recalling 3,734 Voyager Rollator walkers due to cracking wheel spokes that may cause wheels to separate from the axle, potentially resulting in patient falls and injuries.
Product
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0512-2022·2022-01-26
Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.
Product
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·22057·2022-01-26
Children's Nightgowns Recalled for Flammability Standard Violation
AOSKERA is recalling approximately 1,000 children's nightgowns sold on Amazon.com from October 2020 through May 2021 because they fail to meet federal flammability standards for children's sleepwear, posing a burn injury risk.
Product
Children's Nightgowns
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0497-2022·2022-01-26
Senior Living Nurse Call Systems Failing to Alarm Due to Memory Issue
Stanley Security Solutions is recalling 11 Senior Living Arial Emergency and Nurse Call Systems because they fail to alarm due to increased memory consumption, potentially preventing nursing staff from responding to resident emergencies.
Product
Senior Living Arial Emergency and Nurse Call Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0499-2022·2022-01-26
FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error
Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.
Product
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0508-2022·2022-01-26
Cardinal Infant Heel Warmer recalled due to unapproved labeling changes
Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.
Product
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2022·2022-01-26
Medical Device Mattress Recalled for Labeling Non-Compliance with FDA Requirements
Philips is recalling 141,750 Infa-Therm Transport Mattresses because modified labeling does not comply with FDA clearance requirements. The devices cannot be distributed or sold without new FDA clearance.
Product
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0381-2022·2022-01-26
Fexofenadine/Pseudoephedrine tablets recalled for failed dissolution
Dr. Reddy's Laboratories is recalling Kroger Allergy Relief-D tablets (fexofenadine HCl 60mg/pseudoephedrine HCl 120mg) due to failed dissolution specifications. Approximately 11,064 boxes distributed nationwide are affected.
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0498-2022·2022-01-26
Medical Device Assay Kits Recalled for Potential Instrument Leakage
Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.
Product
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0506-2022·2022-01-26
Infant Heel Warmers Recalled for Unauthorized Labeling Changes
Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.
Product
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0391-2022·2022-01-26
Extra Strength Headache tablets recalled for CGMP manufacturing deviations
Medique Products is recalling Extra Strength Headache tablets nationwide after an FDA inspection found they were not manufactured under Current Good Manufacturing Practices.
Product
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0386-2022·2022-01-26
Leader 12HR Allergy & Congestion Relief tablets fail dissolution test
Dr. Reddy's Laboratories is recalling Leader brand 12HR Allergy & Congestion Relief tablets due to failed dissolution specifications. The product may not release its active ingredients properly.
Product
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0373-2022·2022-01-26
Brinzolamide Ophthalmic Suspension recalled for defective container caps
Teva Pharmaceuticals is recalling Brinzolamide Ophthalmic Suspension 1% due to defective container caps. The notch in the dropper cap could break off and block dispensing of the medication.
Product
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0374-2022·2022-01-26
Clobetasol Propionate Foam Recalled for CGMP Deviations
Ingenus Pharmaceuticals is recalling 45,173 cans of Clobetasol Propionate Foam, 0.05%, nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, FDA Class II recall.
Product
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0389-2022·2022-01-26
Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations
Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.
Product
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0385-2022·2022-01-26
CVS Health Allergy Relief D Tablets Recalled for Failed Dissolution
CVS Health Allergy Relief D Extended Release Tablets are being recalled because they failed to meet dissolution specifications. The recall affects 41,784 boxes distributed nationwide.
Product
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0390-2022·2022-01-26
Medique Pain-Off Tablets Recalled for Manufacturing Practice Violations
Medique Products is recalling Medique Pain-Off tablets nationwide after an FDA inspection found the products were not manufactured under Current Good Manufacturing Practices.
Product
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x…
Category
Drug
Distribution
Distributed nationwide
ModerateCPSC·22061·2022-01-26
Family Dollar Recalls Beach Loungers Due to Collapse Injury Hazard
Family Dollar is recalling about 800 beach lounge chairs that can collapse unexpectedly, risking finger entrapment in metal folding joints. The loungers were sold nationwide from January 2019 through September 2021.
Product
Beach Loungers
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0376-2022·2022-01-26
Clobazam Oral Suspension Recalled for Failed Stability Specifications
VistaPharm is recalling Clobazam Oral Suspension 2.5 mg/mL due to failed stability specifications. The recall affects 18,456 bottles distributed nationwide.
Product
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0387-2022·2022-01-26
Lexette Topical Foam Recall Due to Dispensing Defects
Mayne Pharma is recalling Lexette (halobetasol propionate) Topical Foam 0.05% due to manufacturing defects that cause the product to either not dispense or dispense liquid instead of foam. The recall affects 17,113 canisters distributed nationwide.
Product
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0384-2022·2022-01-26
QC Quality Choice Fexofenadine/Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling QC Quality Choice Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg Extended-Release Tablets nationwide due to failed dissolution specifications that may reduce the medication's effectiveness.
Product
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0383-2022·2022-01-26
Equate Allergy Relief D Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Equate Allergy Relief D Extended-Release Tablets distributed by Walmart nationwide due to failed dissolution specifications. The recall affects 137,856 boxes across multiple lot numbers.
Product
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0507-2022·2022-01-26
Heel Snuggler devices recalled for labeling changes without FDA approval
Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.
Product
Heel Snuggler, Reference # 989805603411 99047
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0382-2022·2022-01-26
Dr. Reddy's Fexofenadine/Pseudoephedrine Tablets Fail Dissolution Specification
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets because the tablets failed to meet dissolution specifications, which may affect the drug's effectiveness.
Product
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ…
Category
Drug
Distribution
Distributed nationwide