The Recall Desk

State

New Jersey product recalls

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

About recalls in New Jersey

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 New Jersey 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.

13051–13075 of 20364

  • 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-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 (Drugs)·D-0854-2023·2023-06-07

    Valproic Acid Oral Solution Recalled for Manufacturing Compliance Deviation

    Akorn, Inc. is recalling all lots of Valproic Acid Oral Solution, USP (250mg/5mL) nationwide. The recall was issued because the firm ceased operations and could not complete required stability studies as mandated by manufacturing regulations.

    Product
    Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    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-0798-2023·2023-06-07

    FDA Recalls DetomiSed Drug Due to Incomplete Stability Testing

    FDA is recalling all lots of DetomiSed (detomidine hydrochloride), a prescription-only drug, nationwide. Akorn Inc., the manufacturer, went out of business and could no longer conduct stability studies.

    Product
    DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. 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-0789-2023·2023-06-07

    FDA Recalls Calcipotriene Scalp Solution Due to Manufacturing Compliance Issues

    Akorn, Inc. is recalling all lots of Calcipotriene Topical Solution 0.005% due to manufacturing compliance failures and incomplete stability studies. The manufacturer ceased operations before completing required stability tests.

    Product
    Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, 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-1658-2023·2023-06-07

    QUADROX-iD Pediatric Oxygenator Recalled Due to Packaging Sterile Barrier Defect

    Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.

    Product
    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0853-2023·2023-06-07

    Akorn Tropicamide Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn recalls all lots of Tropicamide Ophthalmic Solution 0.5% (15 mL bottles) nationwide due to CGMP deviations. The firm was unable to complete required stability studies after ceasing operations.

    Product
    Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, 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 (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-1670-2023·2023-06-07

    Smith & Nephew ENGAGE Cementless Knee System Recalled Over Revision Rate Concerns

    Smith & Nephew has recalled 1,994 units of its ENGAGE Cementless Partial Knee System because recent data shows higher-than-expected revision rates compared to similar devices.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0772-2023·2023-06-07

    Cough medicine recalled due to manufacturing process deviation with non-food lubricant

    Denison Pharmaceuticals is recalling Safe tussin DM DAY TIME Cough Relief due to use of non-food grade lubricant in the manufacturing process. Approximately 86,616 bottles were distributed nationwide.

    Product
    Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2023·2023-06-07

    Smith & Nephew ENGAGE Knee System Recalled for Elevated Revision Risk

    Smith & Nephew's ENGAGE Cementless Partial Knee System is being recalled due to higher-than-expected revision rates compared to similar devices. The recall affects 7,531 units distributed nationwide.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0826-2023·2023-06-07

    Lorazepam Oral Concentrate Recalled Due to Manufacturing Practice Deviations

    Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate (2 mg/mL) due to Current Good Manufacturing Practice deviations. The manufacturer went out of business and could not complete required stability studies.

    Product
    Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0773-2023·2023-06-07

    Colic Calm Homeopathic Medicine Recalled for Manufacturing Contamination

    Denison Pharmaceuticals is recalling Colic Calm, a homeopathic medicine, due to non-food grade lubricant used in the mixing vessel during manufacturing. Affected lot 8290V was distributed nationwide.

    Product
    Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
    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-0820-2023·2023-06-07

    Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations

    Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.

    Product
    Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0839-2023·2023-06-07

    Proparacaine HCl Ophthalmic Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution 0.5% due to manufacturing deviations. The manufacturer could not complete required stability studies before going out of business.

    Product
    Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, 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-0790-2023·2023-06-07

    FDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations

    FDA is recalling all lots of Calcitriol Injection 1 mcg/mL due to current good manufacturing practice (CGMP) violations. The manufacturer went out of business and could not complete required stability studies.

    Product
    Calcitriol Injection 1 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-1668-2023·2023-06-07

    Medical Device Recall: X-Ray Detector Drive Shaft May Break

    The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.

    Product
    Intelli-C, Right side suspended Tabletop, REF: 03400000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2023·2023-06-07

    X-Ray Machine Detector May Move Unexpectedly Due to Drive Shaft Failure

    FDA recalls the Intelli-C X-Ray machine's left side suspended tabletop model due to potential drive shaft failure in the detector lift mechanism, which could cause uncontrolled detector movement.

    Product
    Intelli-C, Left side suspended Tabletop, REF: 03400010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0836-2023·2023-06-07

    Prednisolone Oral Solution Recalled Due to Manufacturing Standards Deviation

    Akorn, Inc. is recalling all lots of Prednisolone Oral Solution 15 mg/5 mL due to a manufacturing standards deviation. The company discontinued required stability studies after ceasing operations.

    Product
    Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide