The Recall Desk

State

New York product recalls

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

About recalls in New York

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 York 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-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-0784-2023·2023-06-07

    FDA Recalls Apraclonidine Ophthalmic Solution Due to Manufacturing Compliance Failures

    Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.

    Product
    Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    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-0834-2023·2023-06-07

    Oxcarbazepine Oral Suspension Recalled Due to Manufacturing and Stability Deviations

    Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.

    Product
    Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0774-2023·2023-06-07

    Pin-Away Pyrantel Pamoate Recalled for Non-Food-Grade Lubricant Use in Manufacturing

    Denison Pharmaceuticals recalls Pin-Away Pyrantel Pamoate pinworm treatment nationwide due to CGMP deviation: non-food-grade lubricant used in the manufacturing mixing vessel.

    Product
    Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2023·2023-06-07

    QUADROX-iD Adult Oxygenator recalled for packaging defect compromising sterile barrier

    Maquet Medical Systems USA recalls 24,250 QUADROX-iD Adult Oxygenators due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices during cardiopulmonary bypass surgery.

    Product
    QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0852-2023·2023-06-07

    Trihexyphenidyl Hydrochloride Oral Solution Recalled for Unverified Stability

    All lots of Trihexyphenidyl Hydrochloride Oral Solution (2mg/5mL) distributed nationwide have been recalled. The manufacturer went out of business and could not complete stability studies needed to verify the drug's safety over time.

    Product
    Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. 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 (Drugs)·D-0851-2023·2023-06-07

    Tobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Tobramycin Ophthalmic Solution 0.3% because the manufacturer went out of business and could not complete required stability studies, a violation of manufacturing regulations.

    Product
    Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1659-2023·2023-06-07

    QUADROX-i Adult Oxygenator Recalled for Packaging Defects Compromising Sterility

    Maquet is recalling QUADROX-i Adult Oxygenators used in cardiopulmonary bypass surgery due to packaging defects that may compromise the sterile barrier. Contact with non-sterile devices could cause infection, sepsis, or ischemia.

    Product
    QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0847-2023·2023-06-07

    Sufenta Injection Recalled Due to Manufacturing Compliance Deviations

    Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.

    Product
    Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0863-2023·2023-06-07

    Ropivacaine Hydrochloride Injection recalled; manufacturer unable to complete stability studies

    Akorn, Inc. recalls all lots of Ropivacaine Hydrochloride Injection nationwide because the manufacturer went out of business and cannot complete required stability studies.

    Product
    Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0845-2023·2023-06-07

    Sodium Chloride Ophthalmic Solution Recalled Due to Incomplete Stability Studies

    Akorn Operating Company is recalling all lots of Sodium Chloride Ophthalmic Solution (5%, 50mg/mL) nationwide because the firm went out of business and could not complete required stability studies to verify product safety and effectiveness.

    Product
    Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, 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 (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-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 (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 (Devices)·Z-1653-2023·2023-06-07

    Knee replacement implant bearing inserts mislabeled with wrong catalog numbers

    Howmedica Osteonics recalled 24 TRIATHLON X3 tibial bearing inserts due to mislabeling, where units labeled with one catalog number may contain a different size. Medical facilities should discontinue use and contact the manufacturer.

    Product
    TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0804-2023·2023-06-07

    Fluticasone Propionate Nasal Spray Recalled Due to Manufacturing Quality Concerns

    Akorn, Inc. is recalling all lots of Fluticasone Propionate Nasal Spray, 50mcg due to manufacturing deviations and inability to verify product stability.

    Product
    Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. 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-0835-2023·2023-06-07

    FDA Recalls Pilocarpine Ophthalmic Solution Due to Incomplete Stability Studies

    Akorn Inc. recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 1% nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies.

    Product
    Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 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-0805-2023·2023-06-07

    FDA Recalls Akorn Gonak Eye Drops for Manufacturing Deviations

    Akorn, Inc. recalled all lots of Gonak Hypromellose Ophthalmic Solution distributed in the USA and Puerto Rico after the firm ceased operations and could not complete required stability studies.

    Product
    Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, 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-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 (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