The Recall Desk

State

Virginia product recalls

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

About recalls in Virginia

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 Virginia 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.

13001–13025 of 20364

  • HighFDA (Drugs)·D-0780-2023·2023-06-07

    Acetaminophen & Codeine Oral Solution Recalled Due to Unverified Stability

    Akorn, Inc. is recalling all lots of Acetaminophen & Codeine Oral Solution because stability studies cannot be completed. The firm ceased operations and cannot verify the medication's potency and safety.

    Product
    Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0838-2023·2023-06-07

    Promethazine HCl Oral Solution Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Promethazine HCl Oral Solution, USP, due to Current Good Manufacturing Practice deviations. The firm went out of business and cannot complete required stability studies.

    Product
    Promethazine HCl Oral Solution, USP, 6.25 mg/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-1654-2023·2023-06-07

    Knee Replacement Insert Mislabeled; Contents May Not Match Catalog Number

    Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during surgery.

    Product
    TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
    Category
    Medical Device
    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 (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-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-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 (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-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 (Drugs)·D-0786-2023·2023-06-07

    FDA Recalls All Lots Akorn Artificial Tears Ointment Nationwide

    Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required stability studies.

    Product
    Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, 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 (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 (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-0811-2023·2023-06-07

    Akorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations

    Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.

    Product
    Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    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-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 (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-0830-2023·2023-06-07

    Naloxone Injection Recall Due to Manufacturing Process Deviations

    Akorn, Inc. is recalling all lots of Naloxone Injection 0.4 mg/mL due to manufacturing process deviations. The manufacturer could not complete required stability studies.

    Product
    Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    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-0792-2023·2023-06-07

    Ciclopirox Topical Solution Recalled Due to Manufacturing Practice Violations

    Ciclopirox 8% topical solution (nail lacquer) is recalled nationwide. The manufacturer went out of business and could not complete required stability testing to ensure product safety.

    Product
    Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. 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-0815-2023·2023-06-07

    Lactulose Solution Recall Due to Manufacturing Practice Deviations

    Akorn, Inc. has recalled all lots of Lactulose Solution, USP 30 mL Unit Dose Cups nationwide due to the company's inability to continue stability studies after ceasing operations.

    Product
    Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., 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-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