The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

18576–18600 of 88183

  • ModerateFDA (Drugs)·D-0801-2023·2023-06-07

    Docusate Liquid Drug Recalled Over Incomplete Stability Testing

    Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.

    Product
    DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0793-2023·2023-06-07

    Cimetidine HCl Oral Solution Recalled Due to Manufacturing Compliance Deviations

    Akorn, Inc. is recalling all lots of Cimetidine HCl Oral Solution 300mg/5mL nationwide due to CGMP deviations. The firm ceased operations and could not complete required stability studies.

    Product
    Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1664-2023·2023-06-07

    VITROS Chemistry Calibrator Kit Cannot Calibrate Vancomycin Reagent

    Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.

    Product
    VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0968-2023·2023-06-07

    Magnesium Citrate Dietary Ingredient Recalled for Excess Yeast and Mold

    Jost Chemical is recalling magnesium citrate dietary ingredient due to yeast and mold levels exceeding specifications. Approximately 73 drums totaling 8,030 pounds distributed to manufacturers in California and Georgia were affected.

    Product
    Jost Chemical Magnesium Citrate Tribasic Hydrate, USP, Powder, Net Wt 110 lb/ 50 kg packaged in bulk lined fiber drums
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0783-2023·2023-06-07

    Albuterol Sulfate Syrup Recalled for Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Albuterol Sulfate Syrup nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies to verify ongoing product safety and effectiveness.

    Product
    Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, 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-0822-2023·2023-06-07

    Lidocaine Ointment USP Recalled Due to Manufacturing Process Deviations

    Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.

    Product
    Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0824-2023·2023-06-07

    Akorn Lidocaine Oral Solution Recalled Due to Manufacturing Compliance Deviations

    Akorn Operating Company is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution 2% distributed nationally because the firm ceased operations and could not complete required stability studies.

    Product
    Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2023·2023-06-07

    Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.

    Product
    Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0779-2023·2023-06-07

    Akorn Atropine Sulfate Eye Drops Recalled Due to Manufacturing Compliance Failures

    Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% because the firm went out of business and could not complete required stability studies. The product was distributed nationwide in the USA and Puerto Rico.

    Product
    Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, 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-0806-2023·2023-06-07

    FDA Recalls Granisetron HCl Injectable Drug Due to Manufacturing Compliance Failure

    Akorn, Inc. recalls all lots of Granisetron HCl Injection nationwide because the manufacturer ceased operations and cannot complete required stability studies, leaving the drug's shelf-life unverified.

    Product
    Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use 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-0791-2023·2023-06-07

    Cetrorelix Acetate Injectable Recalled Due to Manufacturing Deviations

    Akorn, Inc. recalls all lots of Cetrorelix Acetate for Injection due to manufacturing process deviations. The company went out of business and could not complete required stability testing.

    Product
    Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0803-2023·2023-06-07

    Ferrous Sulfate Iron Supplement Drops Recalled for Manufacturing Stability Issues

    All lots of Ferrous Sulfate Iron Supplement Drops are being recalled nationwide. The manufacturer went out of business and cannot complete required stability studies to verify product safety.

    Product
    Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0782-2023·2023-06-07

    Acyclovir Oral Suspension Recalled for Manufacturing Practice Deviations

    Akorn's Acyclovir Oral Suspension is being recalled nationwide due to manufacturing practice deviations. The firm closed and could not complete required stability studies for the medication.

    Product
    Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0794-2023·2023-06-07

    Clobetasol Propionate Cream Recalled Due to CGMP Violations and Unverified Stability

    Akorn, Inc. is recalling all lots of Clobetasol Propionate Cream 0.05% nationwide because the manufacturer went out of business before completing required stability studies to verify product safety and efficacy.

    Product
    Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, 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
  • ModerateFDA (Drugs)·D-0844-2023·2023-06-07

    Akorn Sodium Chloride Ophthalmic Ointment Recalled Due to Manufacturing Deviations

    Akorn Inc. is recalling all lots of Sodium Chloride Ophthalmic Ointment 5% nationwide due to manufacturing practice deviations. The company ceased operations and could not continue stability studies required to verify the product's safety and effectiveness.

    Product
    Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0850-2023·2023-06-07

    Tobramycin Inhalation Solution Recalled Due to Incomplete Stability Studies

    All lots of Tobramycin Inhalation Solution manufactured by Akorn, Inc. have been recalled nationwide due to CGMP deviations. The manufacturer was unable to complete required stability studies before ceasing operations.

    Product
    Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0925-2023·2023-05-31

    Lay's Potato Chips Recalled for Undeclared Milk Allergen

    Frito-Lay is recalling Lay's Classic Potato Chips due to undeclared milk. The recall affects specific products distributed in Connecticut, Massachusetts, Maine, and New Hampshire.

    Product
    Lay s Classic Party Size Potato Chips 13 oz. (368.5 g) UPC 028400310413 packaged in a yellow flexible bag and Lay s Classic Mix and Match Potato Chips 15 5/8 oz (442.9 g) UPC 0028400720151 packaged in a yellow flexible bag
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-1618-2023·2023-05-31

    Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption

    BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.

    Product
    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was…
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Food)·F-0929-2023·2023-05-31

    Washington Crab Crabcakes Recalled Due to Undeclared Allergens

    Washington Crab & Seafood Company recalls crabcakes due to undeclared allergens: egg, wheat, and soy. The product was distributed to North Carolina and South Carolina.

    Product
    CRABCAKE Ingredients: Blue Crabmeat, mayonnaise, onion bread crumbs, egg solids, salt, spices paprika WASHINGTON CRAB Carolina seafood
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0924-2023·2023-05-31

    Lancaster Spinach Recalled for Possible Listeria Contamination

    Lancaster Spinach, 10-ounce packages, is recalled due to possible contamination with Listeria monocytogenes. Products were distributed in Massachusetts, Maryland, Pennsylvania, New York, New Jersey, and Virginia.

    Product
    LANCASTER SPINACH, 10 OZ, UPC:8-13055-01145-3. Packaged in sealed plastic bags, 12 in a case.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1594-2023·2023-05-31

    COVID-19 At-Home Test Kits Recalled for Bacterial Buffer Contamination

    SD Biosensor is recalling 2,712,767 Pilot COVID-19 At-Home Test kits nationwide due to bacterial contamination in the liquid buffer component. Users may notice an odor from affected kits.

    Product
    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
    Category
    Medical Device
    Distribution
    Distributed nationwide