State

Pennsylvania product recalls

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

About recalls in Pennsylvania

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 Pennsylvania 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.

15576–15600 of 20364

HighFDA (Drugs)·D-1520-2022·2022-09-21
Carolina Infusion Semaglutide/Cyanocobalamin Injectable Recalled for Sterility Issue
Carolina Infusion is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable syringes nationwide due to lack of sterility assurance. The affected lot 08152022@14 has a best-by date of September 14, 2022.
Product
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1525-2022·2022-09-21
FDA Recalls Test Cypionate/Propionate Injectable for Lack of Sterility Assurance
Carolina Infusion is recalling TEST CYP/PROP 100 MG/100 MG/ML injectable vials due to lack of assurance of product sterility. Patients should contact their healthcare provider.
Product
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1523-2022·2022-09-21
Carolina Infusion Injectable Hormones Recalled Due to Sterility Concerns
Carolina Infusion is recalling TEST CYP/DHEA injectable hormone products due to lack of sterility assurance. The recall affects nationwide distribution of 3 ML and 6 ML vials.
Product
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1528-2022·2022-09-21
TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.
Product
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1709-2022·2022-09-21
Roadrunner PC Wire Guide Recalled for Sterility Testing Failure
Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1532-2022·2022-09-21
TRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 50/2.5/25 Injectable (Lot 07052022@2) nationwide due to lack of assurance of sterility. Patients should not use affected vials and should consult their healthcare provider.
Product
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1531-2022·2022-09-21
Injectable drug recalled due to lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.
Product
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1707-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure
Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1529-2022·2022-09-21
Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/60 Injectable (5 ML vials) nationwide due to lack of assured sterility. The affected lots have Beyond Use Dates in August and September 2022. Contact your healthcare provider if you received this product.
Product
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1714-2022·2022-09-21
Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2022·2022-09-21
Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise
Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2022·2022-09-21
FUJIFILM Surpria Imaging Software May Fail During Scanning
Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.
Product
Surpria: Software Version V3.11, V3.22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2022·2022-09-21
Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1725-2022·2022-09-21
GXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect
Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1536-2022·2022-09-21
Lisinopril Tablets Recalled for Embedded Metal Contamination
Lupin Pharmaceuticals is recalling Lisinopril 10 mg tablets due to discovery of a metal piece embedded in one tablet. Affected lot Q201182 was distributed nationwide to wholesalers.
Product
LISINOPRIL — LISINOPRIL (LISINOPRIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2022·2022-09-21
Vascular wire guides recalled due to potential sterility compromise
Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure
Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2022·2022-09-21
SCENARIA View software error may require additional patient radiation exposure
SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.
Product
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2022·2022-09-21
Vascular Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2022·2022-09-21
Sterile Dental Rolls Recalled: New Cotton Source Sterility Not Validated
Carwild Corporation is recalling FABCO ORS Dental Rolls because the sterility of a new cotton source was not validated. The recalled 90 cases (4,500 units) with lot 22B0428 were distributed nationwide.
Product
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging Bags
Exactech recalls GXL acetabular hip implant liners packaged in non-conforming bags that may cause premature wear. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2022·2022-09-21
ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment
A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.
Product
ZAP-X Radiosurgery System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1732-2022·2022-09-21
Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear
Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1518-2022·2022-09-21
Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance
Carolina Infusion is recalling Sermorelin Acetate injectable (1 MG/ML, 9 ML syringes) distributed nationwide due to lack of assurance of sterility. The manufacturer could not adequately document that the product meets required sterility standards.
Product
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1539-2022·2022-09-21
Teva Amphetamine Tablets Recalled Due To Incorrect Strength Labeling
Teva Pharmaceuticals is recalling 83,703 bottles of prescription amphetamine tablets nationwide because bottles labeled as 15 mg strength actually contain 20 mg tablets, creating risk of unintended overdose. Patients should contact their pharmacy or healthcare provider.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide