The Recall Desk

State

Iowa product recalls

20,308 recalls have nationwide distribution and so reach Iowa. 0 additional recalls listed Iowa specifically in their distribution scope.

About recalls in Iowa

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 Iowa 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 20308

  • 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-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-0800-2023·2023-06-07

    Diuril Injectable Drug Recalled Due to Manufacturing Quality Deviations

    Akorn, Inc. is recalling all lots of Diuril (chlorothiazide sodium) Injection, 500mg/vial, distributed nationwide, due to manufacturing deviations. The manufacturer went out of business and was unable to complete required stability studies.

    Product
    Diuril (chlorothiazide sodium) Injection, 500mg/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-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-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-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-1635-2023·2023-06-07

    Oxygenator devices recalled due to packaging damage compromising sterile barrier

    Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.

    Product
    BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
    Category
    Medical Device
    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-0807-2023·2023-06-07

    Akorn Guaiatussin AC Sugar-Free Cough Suppressant Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free nationwide due to manufacturing deviations. The firm went out of business and could not continue stability studies.

    Product
    Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    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-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-1639-2023·2023-06-07

    Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier

    Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.

    Product
    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0837-2023·2023-06-07

    Promethazine HCl & Codeine Phosphate Oral Solution Recalled Due to Manufacturing Compliance Deviations

    Akorn Inc. is recalling all lots of Promethazine HCl & Codeine Phosphate Oral Solution nationwide because the firm went out of business and cannot complete required stability studies.

    Product
    Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, 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 (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-0785-2023·2023-06-07

    Artificial Tears Solution Recalled Due to CGMP Deviations and Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) nationwide due to CGMP compliance issues and inability to complete required stability studies after the firm went out of business.

    Product
    Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0816-2023·2023-06-07

    Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing

    Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.

    Product
    Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2023·2023-06-07

    Smith & Nephew Knee Prosthesis Recalled Due to Higher-Than-Expected Revision Rate

    Smith & Nephew is recalling 1,596 units of its ENGAGE Cementless Partial Knee System due to complaint data indicating higher revision rates than comparable devices. Patients should consult their surgeon.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0802-2023·2023-06-07

    Ephedrine Sulfate Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection due to manufacturing compliance deviations; the firm was unable to complete required stability studies.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. 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
  • ModerateFDA (Drugs)·D-0833-2023·2023-06-07

    Olopatadine HCl Eye Drops Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1% eye drops due to Current Good Manufacturing Practice deviations. The manufacturer discontinued required stability studies after ceasing operations.

    Product
    Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0781-2023·2023-06-07

    Acetic Acid Otic Solution recalled due to manufacturing deviations and unverified stability

    Akorn is recalling all lots of Acetic Acid Otic Solution nationwide due to manufacturing practice deviations. The firm went out of business and could not complete stability studies required to verify the product remained safe and effective.

    Product
    Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0778-2023·2023-06-07

    Compounded Phenylephrine Solution Recalled Due to Wrong Base Diluent

    Advanced Compounding Solutions is recalling a compounded phenylephrine solution made with 5% Dextrose instead of the correct 0.9% Sodium Chloride diluent. The error affects 198 units distributed nationwide.

    Product
    Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2023·2023-06-07

    Tropicamide Ophthalmic Solution Recalled by Akorn for CGMP Deviations

    Akorn Operating Company is recalling all lots of Tropicamide Ophthalmic Solution 0.1% nationwide due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and could not complete required stability studies.

    Product
    Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0796-2023·2023-06-07

    Clobetasol Propionate Shampoo Recall Due to Manufacturing Compliance Issues

    Akorn, Inc. is recalling all lots of Clobetasol Propionate Shampoo, 0.05% distributed nationwide after the firm closed and could not continue required stability studies.

    Product
    Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide