State

Hawaii product recalls

20,364 recalls have nationwide distribution and so reach Hawaii. 0 additional recalls listed Hawaii specifically in their distribution scope.

About recalls in Hawaii

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 Hawaii 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.

13701–13725 of 20364

HighFDA (Devices)·Z-1332-2023·2023-04-12
Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall
Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.
Product
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Deminera
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1340-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery
Stryker tourniquet cuffs may fail to maintain proper pressure during initial setup, potentially causing operative blood loss or hemorrhage during surgical procedures.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0489-2023·2023-04-12
Testosterone Cypionate Injection Recalled for Manufacturing Defect
Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection due to complaints that crystals fail to redissolve after warming and shaking, a manufacturing quality defect affecting specific lots nationwide.
Product
TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0513-2023·2023-04-12
Clopidogrel Tablets 75 mg Recalled for Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.
Product
Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0521-2023·2023-04-12
Pravastatin Sodium Tablets Recalled Due to Manufacturing Deviations
Preferred Pharmaceuticals is recalling Pravastatin Sodium 20 mg tablets nationwide due to manufacturing practice deviations identified during FDA inspection. No illnesses have been reported.
Product
Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1336-2023·2023-04-12
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Recalled for Sterilization Failure
Maquet Cardiovascular is recalling approximately 2,300 units of the VASOVIEW HEMOPRO 2 system because some batches were not sterilized to specification. This sterilization failure creates a risk of contamination and potential infection during surgical procedures.
Product
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2023·2023-04-12
Tempus Pro Patient Monitor power supplies recalled for fluid ingress and safety issues
Remote Diagnostic Technologies is recalling 5,540 Tempus Pro Patient Monitors due to fluid ingress and basic safety issues identified with power supplies during internal testing.
Product
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supp
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0523-2023·2023-04-12
Simvastatin Tablets, USP, 80 mg Recalled Due to Manufacturing Deviations
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 80 mg due to manufacturing quality control deviations identified at Accord Healthcare during FDA inspection. Approximately 57 bottles distributed nationwide.
Product
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0494-2023·2023-04-12
Ropinirole 0.5 mg tablets recalled for manufacturing quality deviations
RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets due to manufacturing process deviations. The product was distributed nationwide within the United States.
Product
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1335-2023·2023-04-12
Endoscopic vessel harvesting system recalled for sterilization defect
900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.
Product
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0497-2023·2023-04-12
Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations
RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.
Product
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0509-2023·2023-04-12
Alprazolam 2 mg tablets recalled due to potential manufacturing cross-contamination
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.
Product
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0527-2023·2023-04-12
Glimepiride Tablets Recall Due to Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.
Product
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2023·2023-04-12
Drug Recall: Simvastatin tablets due to manufacturing deviations
RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.
Product
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2023·2023-04-12
Prescription Tadalafil tablets recalled for manufacturing process deviations
Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0517-2023·2023-04-12
Glimepiride Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1320-2023·2023-04-12
Biosense Webster guiding sheath recalled for labeling mismatch
Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2023·2023-04-12
Doxazosin Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling Doxazosin Tablets, USP, 4 mg (lot L1522V, expiration 4/30/2025) due to current Good Manufacturing Practice deviations discovered during FDA inspection of the manufacturer, Accord Healthcare. The product was distributed nationwide.
Product
Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2023·2023-04-12
Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations
RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0516-2023·2023-04-12
Finasteride Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling specific lots of Finasteride Tablets, 5 mg due to manufacturing process deviations discovered during FDA inspection of manufacturer Accord Healthcare. No illnesses or injuries have been reported.
Product
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0491-2023·2023-04-12
Drug Recall: Atorvastatin 10 mg tablets due to manufacturing process violations
RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated March 20, 2023.
Product
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0502-2023·2023-04-12
Rosuvastatin 40mg tablets recalled nationwide for manufacturing process deviations
RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.
Product
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0514-2023·2023-04-12
Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations
Preferred Pharmaceuticals recalls Doxazosin Tablets USP 2 mg (Lot H3122K, expires 5/31/2024) due to current Good Manufacturing Practice deviations identified at the manufacturing facility.
Product
Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2023·2023-04-12
Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns
Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.
Product
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0490-2023·2023-04-12
Drug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.
Product
Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
Category
Drug
Distribution
Distributed nationwide