State

Montana product recalls

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

About recalls in Montana

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 Montana 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.

6651–6675 of 20096

HighFDA (Drugs)·D-0095-2025·2024-12-11
Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2025·2024-12-11
Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits
Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2025·2024-12-11
MEDLINE dental and oral surgery kits recalled due to defective component
MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
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-0630-2025·2024-12-11
Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.
Product
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF
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-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 (Drugs)·D-0090-2025·2024-12-11
ROYALAB Germ Away Antibacterial Hand Soap Recalled for Failed Microbiological Testing
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
Product
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Category
Drug
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 (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 (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 (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-0629-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0077-2025·2024-12-11
FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
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-0638-2025·2024-12-11
MEDLINE medical convenience kits recalled for defective component
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0094-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits
Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0112-2025·2024-12-11
Prescription Drug Lisdexamfetamine Dimesylate Recalled for Failed Content Uniformity
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
Product
LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
Category
Drug
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-0640-2025·2024-12-11
MEDLINE convenience kits recalled due to defective component
Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0110-2025·2024-12-11
Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits
AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.
Product
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0622-2025·2024-12-11
Medline Tracheostomy Convenience Kits Recalled Due to Defective Component
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0080-2025·2024-12-11
Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination
American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.
Product
VENOFER — VENOFER (IRON SUCROSE)
Category
Drug
Distribution
Distributed nationwide