State

South Carolina product recalls

20,322 recalls have nationwide distribution and so reach South Carolina. 0 additional recalls listed South Carolina specifically in their distribution scope.

About recalls in South Carolina

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 South Carolina 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.

12976–13000 of 20322

HighFDA (Devices)·Z-1637-2023·2023-06-07
QUADROX-i Small Adult Oxygenator Recall Due to Sterile Packaging Defects
Maquet is recalling QUADROX-i Small Adult Oxygenators due to packaging defects that may compromise the sterile barrier. Exposure to non-sterile product could cause infection, sepsis, and ischemia.
Product
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0841-2023·2023-06-07
Rifampin Capsules Recall: Incomplete Stability Studies Due to Manufacturer Closure
Akorn Inc. is recalling all lots of Rifampin Capsules USP 300 mg distributed nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required testing.
Product
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0814-2023·2023-06-07
Akorn Lactulose Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Lactulose Solution USP (Oral), 10g/15mL, distributed nationwide in the USA and Puerto Rico, due to the manufacturer's inability to complete required stability studies following company closure.
Product
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0823-2023·2023-06-07
Lidocaine HCl Jelly 2% recalled nationwide for manufacturing compliance deviations
Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.
Product
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1640-2023·2023-06-07
QUADROX-i Neonatal oxygenator recalled for compromised sterile packaging
Maquet Medical Systems is recalling QUADROX-i Neonatal oxygenators due to packaging defects that may compromise sterility. Improper accessory placement and packaging damage could expose the device to contamination, risking infection and sepsis.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0840-2023·2023-06-07
Rifampin Capsules Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg distributed nationwide due to manufacturing deviations. The company ceased business before completing required stability studies to verify the drug remains safe and effective throughout its shelf life.
Product
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2023·2023-06-07
QUADROX-i Pediatric Oxygenator Packaging Defects Compromise Sterile Barrier
FDA Class II recall of QUADROX-i Pediatric oxygenators due to packaging defects—creases, holes, cracks—that compromise sterile barriers, risking infection and sepsis during cardiopulmonary bypass procedures.
Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects
Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0831-2023·2023-06-07
Neomycin and Polymyxin B Eye Ointment Recalled for Incomplete Stability Studies
Akorn, Inc. has recalled all lots of Neomycin & Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment due to inability to complete required stability studies following the firm's business closure.
Product
Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0812-2023·2023-06-07
FDA Recalls IC-Green Injectable Drug: Manufacturing Deviations Prevent Stability Verification
Akorn, Inc. recalled all lots of IC-Green injectable drug nationwide because the firm went out of business and could not complete stability studies required to verify manufacturing compliance.
Product
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0809-2023·2023-06-07
HydrALAZINE Injection Recalled Due to Manufacturing Deviations and Unverified Stability
Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection nationwide because the manufacturer ceased operations and could no longer conduct required stability studies.
Product
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0859-2023·2023-06-07
Akorn Midazolam Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Midazolam Injection nationwide due to manufacturing practice deviations. The company ceased operations and could not complete stability studies to verify the drug's safety and efficacy.
Product
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1644-2023·2023-06-07
EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings
Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.
Product
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2023·2023-06-07
Partial Knee Implant Recall Due to Higher-Than-Expected Revision Rates
Smith & Nephew is recalling 2,146 cementless partial knee implants (ENGAGE system) due to complaint data showing higher-than-expected revision rates compared to similar devices.
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0858-2023·2023-06-07
Calcitriol Injection 2 mcg/mL Recalled Due to CGMP Deviations by Akorn, Inc.
Akorn recalled all lots of Calcitriol Injection 2 mcg/mL nationwide due to CGMP deviations and inability to complete stability studies after the firm went out of business.
Product
Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1660-2023·2023-06-07
QUADROX-i Neonatal Oxygenator packaging may compromise sterile barrier
QUADROX-i Neonatal Oxygenators may have small pinholes in packaging that compromise the sterile barrier, potentially exposing the device to non-sterile conditions and risk of infection, sepsis, or ischemia.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1655-2023·2023-06-07
QUADROX-i Pediatric Oxygenators Recalled for Packaging Sterility Defects
QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, infection, sepsis, or ischemia.
Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1645-2023·2023-06-07
EarlyVue VS30 Vital Signs Monitor Missing Calibration Alarm
Philips is recalling 1,421 EarlyVue VS30 Vital Signs Monitor units in the U.S. because a missing calibration alarm can cause inaccurate CO2 measurements and failure to detect critical patient condition changes.
Product
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0861-2023·2023-06-07
Pilocarpine Hydrochloride Ophthalmic Solution Recall Due to Manufacturing Deviations
Akorn Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution 2% due to manufacturing deviations that prevented completion of stability studies. The product was distributed nationwide in the USA and Puerto Rico.
Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0843-2023·2023-06-07
Fentanyl Citrate Injection Nationwide Recall Due to Manufacturing Compliance Deviations
Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.
Product
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0846-2023·2023-06-07
Akorn Recalls All Lots of Sodium DIURIL Injectable Due to CGMP Deviations
Akorn Operating Company recalls all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial due to Current Good Manufacturing Practice deviations. The manufacturer was unable to complete required stability studies after the firm ceased operations.
Product
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0810-2023·2023-06-07
Hydrocortisone and Acetic Acid Otic Solution Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.
Product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1661-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoir packaging pinholes may compromise sterility
Maquet Medical Systems is recalling Venous Hardshell Cardiotomy Reservoirs because packaging pinholes may compromise the sterile barrier, potentially exposing patients to non-sterile devices that could cause infection or sepsis.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1662-2023·2023-06-07
QUADROX-iR Heart-Lung Oxygenator Recalled for Sterile Barrier Packaging Defect
Maquet Medical is recalling QUADROX-iR oxygenators used in heart-lung bypass procedures due to potential pinholes in packaging that may compromise the sterile barrier, creating risk of serious infection.
Product
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0860-2023·2023-06-07
Prescription eye solution recalled due to discontinued stability studies
Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% because the company went out of business and can no longer conduct required stability testing.
Product
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide