State

Utah product recalls

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

About recalls in Utah

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 Utah 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-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-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-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-0857-2023·2023-06-07
Amantadine Hydrochloride Oral Solution Recalled Due to CGMP Deviations
Akorn, Inc. is recalling all lots of Amantadine Hydrochloride Oral Solution (50mg/5mL) nationwide due to inability to complete required stability studies following the firm's closure, resulting in manufacturing quality deviations.
Product
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
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-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-0827-2023·2023-06-07
Megestrol Acetate Oral Suspension Recalled for Incomplete Stability Studies
Akorn recalled all lots of Megestrol Acetate Oral Suspension nationwide due to the firm's inability to complete required stability studies after ceasing operations.
Product
Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 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 (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-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 (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-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 (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-0828-2023·2023-06-07
Midazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
Akorn, Inc. is recalling all lots of Midazolam Injection USP 2mg/2mL nationwide because the manufacturer went out of business and cannot complete required stability studies mandated by Current Good Manufacturing Practice regulations.
Product
Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. 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-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-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-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 (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-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-0795-2023·2023-06-07
Clobetasol Propionate Ointment recalled due to manufacturing compliance failures
Akorn, Inc. is recalling all lots of Clobetasol Propionate Ointment 0.05% due to manufacturing practice violations and inability to complete required stability studies. Product was distributed nationwide in the USA and Puerto Rico.
Product
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
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
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-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-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