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.

22976–23000 of 88183

  • HighFDA (Drugs)·D-1355-2022·2022-08-24

    Avant Foaming Hand Sanitizer Recalled Due to Manufacturing Process Deviation

    Aire-Master of America Inc. is recalling Avant Foaming Hand Sanitizer because the deionized water system used in manufacturing lacked appropriate microbial control measures.

    Product
    Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1346-2022·2022-08-24

    Injectable Bupivacaine Recalled Due to Manufacturing Cross-Contamination Risk

    Nephron Sterile Compounding Center is recalling 2,030 bags of injectable bupivacaine due to potential cross-contamination from manufacturing process defects. No illnesses have been reported.

    Product
    PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2022·2022-08-24

    FDA Recalls Echelon-14 Microcatheters Due to Moisture-Exposed Packaging

    Micro Therapeutics is recalling Echelon-14 microcatheters whose outer carton packaging was exposed to a wet substance during transport, posing a risk to device sterility.

    Product
    Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2022·2022-08-24

    Echelon-14 Micro Catheter Recall Due to Moisture Exposure During Transport

    Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.

    Product
    Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1546-2022·2022-08-24

    Factor Sweet Pea Risotto recalled for glass in rice ingredient

    Factor is recalling 849 units of Sweet Pea Risotto & Roasted Brussel Sprouts due to glass fragments in the arborio rice ingredient. No illnesses have been reported.

    Product
    Factor Sweet Pea Risotto & Roasted Brussel Sprouts 17.6 oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1518-2022·2022-08-24

    Abbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration

    Abbott Molecular is recalling the Alinity m System due to incorrect optical calibration. The affected unit (Serial Number 00654) was distributed to Italy.

    Product
    The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1549-2022·2022-08-24

    Factor Ready-to-Eat Meals Recalled Due to Glass in Arborio Rice

    Factor is recalling 10,545 units of Summertime Filet & Sweet Corn Risotto meals (best-by 07/20/2022) because the arborio rice ingredient contains glass fragments.

    Product
    Factor Summertime Filet & Sweet Corn Risotto with Sweet Peach-Berry Crumble & Zucchini Medley 15.2oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1560-2022·2022-08-24

    Sweet Loren's Place and Bake Sugar Cookie Dough Recalled for Undeclared Gluten

    Sweet Loren's Place and Bake Sugar Cookie Dough labeled as gluten-free has been recalled because it actually contains gluten. This poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Sweet Loren's Place and Bake Sugar Cookie Dough, Net Wt. 12 oz.
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-1548-2022·2022-08-24

    Medical dressing tray mislabeled as latex-free but contains natural rubber latex

    Trinity Sterile's IV catheter dressing trays are mislabeled as latex-free despite containing natural rubber latex in component 94-7002, risking allergic reactions in latex-sensitive users.

    Product
    Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1335-2022·2022-08-24

    Drug Recall: Incorrect Syringe in ZYNRELEF Anesthetic Delivery Kits

    Heron Therapeutics is recalling 1,790 kits of ZYNRELEF (bupivacaine and meloxicam) distributed nationwide because one lot contains an incorrect syringe in the delivery system. No illnesses or injuries have been reported.

    Product
    ZYNRELEF — ZYNRELEF (BUPIVACAINE AND MELOXICAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2022·2022-08-24

    Contact Lens Solution Recalled for Improper Temperature Storage

    OPTI FREE REPLENISH contact lens solution sold at Family Dollar stores (May 1–June 10, 2022) was not stored in temperature-controlled areas and is being recalled.

    Product
    OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2022·2022-08-24

    Clear Eyes Contact Lens Drops Recalled for Improper Storage

    Family Dollar Stores is recalling Clear Eyes Contact Lens Drops Lubricating due to improper storage in non-temperature-controlled areas. The product was sold nationwide between May 1 and June 10, 2022.

    Product
    CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1558-2022·2022-08-24

    Sensis Signal Input Box recall for patient electrical leakage hazard with improper mounting

    Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.

    Product
    AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2022·2022-08-24

    First Response 2-Count Pregnancy Test Recalled for Improper Storage

    Family Dollar Stores is recalling First Response 2 CT pregnancy tests due to improper storage outside temperature-controlled areas. Affected products were sold nationwide between May 1 and June 10, 2022.

    Product
    FIRST RESPONSE 2 CT, SKU 902343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1352-2022·2022-08-24

    Acetaminophen 325 mg tablets recalled for missing imprint

    Akorn Pharma is recalling 301,382 bottles of Acetaminophen 325 mg tablets because the tablets lack the required "AP 325" imprint marking.

    Product
    Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1343-2022·2022-08-24

    Rifampin Capsules Recalled Due to Manufacturing Control Deviation

    Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1539-2022·2022-08-24

    Poligrip Denture Adhesive Products Recalled for Improper Storage Conditions

    Family Dollar Stores recalls multiple Poligrip denture adhesive products due to improper storage outside temperature-controlled areas. Affected products were sold between May 1 and June 10, 2022.

    Product
    POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1349-2022·2022-08-24

    Azacitidine for Injection Recalled Nationwide for Subpotent Dosage

    Amerisource Health Services is recalling 4,160 vials of Azacitidine for Injection nationwide due to subpotency. The affected vials may contain less than the labeled 100 mg of active ingredient.

    Product
    Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1358-2022·2022-08-24

    Hand Sanitizer Recalled for Manufacturing Process Deficiency

    Protect U Guard Foaming Hand Sanitizer is being recalled due to a manufacturing deficiency in the deionized water system. The product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1536-2022·2022-08-24

    CURAD Waterproof Bandages Recalled for Improper Storage

    Family Dollar is recalling CURAD waterproof bandages due to improper storage outside temperature-controlled conditions. The recall affects approximately 419 units sold nationwide between May 1 and June 10, 2022.

    Product
    CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1544-2022·2022-08-24

    Polident Denture Cleansers Recalled Due to Improper Storage

    Polident denture cleansers sold at Family Dollar stores nationwide are being recalled due to improper storage conditions. No illnesses or injuries have been reported.

    Product
    POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2022·2022-08-24

    VeriQuick Pregnancy Tests Recalled Due to Improper Storage

    Family Dollar is recalling VeriQuick pregnancy tests that were not stored in temperature-controlled areas between April-June 2022. Improper storage conditions may affect test accuracy.

    Product
    VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2022·2022-08-24

    Travel Kit Toothbrush and Toothpaste Recalled Due to Improper Storage

    Family Dollar is recalling approximately 1,555 travel kit toothbrush and toothpaste pouches that were stored in non-temperature-controlled areas. Products sold between May 1 and June 10, 2022 are affected.

    Product
    TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1353-2022·2022-08-24

    Akorn Pharma recalls Acetaminophen 500 mg tablets with missing imprints

    Akorn Pharma, Inc. is recalling Acetaminophen 500 mg Extra Strength tablets because the imprint identification marking is missing from the tablets. The recall affects 30,325 bottles distributed to wholesalers.

    Product
    Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1542-2022·2022-08-24

    At-home marijuana test strips recalled for improper storage

    Family Dollar is recalling at-home marijuana test strips (SKU 900752) that were stored outside temperature-controlled areas. Improper storage may affect test accuracy.

    Product
    AT HOME MARIJUANA TEST STRIP, SKU 900752
    Category
    Medical Device
    Distribution
    Distributed nationwide