State

Indiana product recalls

20,096 recalls have nationwide distribution and so reach Indiana. 0 additional recalls listed Indiana specifically in their distribution scope.

About recalls in Indiana

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Indiana consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

6676–6700 of 20096

HighFDA (Devices)·Z-0631-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Component
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
Product
MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0584-2025·2024-12-11
BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party
BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.
Product
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling L&D convenience kits distributed nationwide because they were manufactured with smoke evacuation pencils that Stryker subsequently recalled. The affected kits contain components from lot 23HMI048.
Product
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0620-2025·2024-12-11
Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0096-2025·2024-12-11
Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0618-2025·2024-12-11
McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect
McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.
Product
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0104-2025·2024-12-11
Sunitinib Malate Capsules Recalled Due to Label Mix-Up
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
Product
SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0590-2025·2024-12-11
Medical Device: BD MAX System Service Credential Breach Poses Unauthorized Access Risk
An unauthorized actor accessed service credentials for Becton Dickinson's BD MAX diagnostic systems. Until credentials are updated, there is risk of unauthorized access that may impact data confidentiality, system integrity, and availability.
Product
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0082-2025·2024-12-11
Prescription Drug Recall: Venofer Iron Sucrose Vials with Glass Delamination Risk
American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.
Product
VENOFER — VENOFER (IRON SUCROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0586-2025·2024-12-11
Medical Device Data Management Software Affected by Unauthorized Service Credential Access
Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.
Product
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0103-2025·2024-12-11
Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall
AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.
Product
SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0632-2025·2024-12-11
MEDLINE Port Insertion Pack Recalled for Defective Component
Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0592-2025·2024-12-11
BD Phoenix M50 Automated Microbiology System Service Credentials Exposed
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.
Product
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0098-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0589-2025·2024-12-11
BD COR GX Instrument recalled due to compromised service credentials
Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.
Product
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0107-2025·2024-12-11
Duloxetine DR Capsules recalled nationwide for nitrosamine impurity
Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.
Product
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0093-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0649-2025·2024-12-11
Medline recalls surgical kits containing Stryker smoke evacuation pencil component
Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0634-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling 14,388 surgical convenience kits nationwide manufactured with certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. Affected kits should not be used.
Product
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, RE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0641-2025·2024-12-11
Medline Surgical Convenience Kits Recalled for Defective Component
Medline is recalling multiple surgical convenience kits because they contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker. The recall affects 1,952 units distributed nationwide; no injuries have been reported.
Product
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0588-2025·2024-12-11
BD COR MX Instruments Affected by Unauthorized Service Credentials Access
BD recalled its COR MX instruments after an unauthorized actor accessed service credentials. The company is updating credentials to prevent future unauthorized access to product data and systems.
Product
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0625-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Component
Medline Industries is recalling 30,092 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0645-2025·2024-12-11
MEDLINE C-Section Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling 58,765 C-section convenience kits nationwide that contain SafeAir Smoke Evacuation Pencil components recalled by manufacturer Stryker. Affected kits have specific lot numbers.
Product
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2025·2024-12-11
Medline Colon Wound Closure Packs recalled due to defective component
Medline is recalling Colon Wound Closure Packs (REF DYNJ52141B) because they were manufactured using SafeAir Smoke Evacuation Pencils that were recalled by Stryker. The kits have been distributed nationwide.
Product
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0646-2025·2024-12-11
MEDLINE Surgical Kits Recalled Due to Defective SafeAir Component
Medline is recalling 3,452 units of surgical convenience kits nationwide due to a defective SafeAir Smoke Evacuation Pencil component previously recalled by Stryker. No illnesses or injuries have been reported.
Product
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF
Category
Medical Device
Distribution
Distributed nationwide