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.

15526–15550 of 27263

  • HighFDA (Drugs)·D-0952-2023·2023-08-09

    Glycopyrrolate Injectable for Anesthesia Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 770 syringes of glycopyrrolate injectable medication nationwide due to lack of validation data for sterilization processes. The product may not meet required sterility standards for safe anesthesia use.

    Product
    glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1346-2023·2023-08-09

    Cassano's Pizza King Dough Recalled for Undeclared Soy Flour

    Cassano's The Pizza King Proprietary Dough is being recalled due to undeclared soy flour. Consumers with soy allergies who consume this product may experience allergic reactions.

    Product
    Cassano's The Pizza King Proprietary Dough: packaged as 6in, 9in, 12in, 14in, and 16in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0949-2023·2023-08-09

    Succinylcholine Injectable Syringes Recalled for Unvalidated Decontamination Cycles

    Central Admixture Pharmacy Services recalls 26,208 succinylcholine injection syringes nationwide due to lack of validated sterilization procedures. The manufacturer lacks adequate validation data for decontamination cycles.

    Product
    succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1339-2023·2023-08-09

    Black Mission Figs Recalled for Undeclared Tree Nuts, Peanuts, Wheat

    Houston Pecan Company is recalling Black Mission Figs in 5-pound bags distributed in Texas and via internet due to undeclared tree nuts, peanuts, and wheat from allergen cross-contamination.

    Product
    Black Mission Figs Potassium Sorbate packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0973-2023·2023-08-09

    FDA Recalls Oxytocin Injectable Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,821 bags of oxytocin IV bags nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.

    Product
    oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2023·2023-08-09

    Surgical Procedural Kits Recalled for Potential Sterility Specification Failures

    Medline Industries is recalling 16,143 custom surgical procedural kits because the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2307-2023·2023-08-09

    Medline Procedural Kits with Turkuaz Ultrasound Gel Recalled for Sterility Concerns

    Medline is recalling custom sterile procedural kits containing Turkuaz ultrasound gel due to potential sterility specification failures. The kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel

    Medline is recalling 6,733 custom procedural kits due to potential sterility failure in the Turkuaz ultrasound gel component. The gel may not meet required sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1057-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled Due to Unvalidated Sanitization Cycles

    Central Admixture Pharmacy is recalling HYDROmorphone injection syringes nationwide due to lack of validated sanitization cycles, which compromises sterility.

    Product
    HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0951-2023·2023-08-09

    FDA recalls dilTIAZem IV bags due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0978-2023·2023-08-09

    Heparin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.

    Product
    heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1319-2023·2023-08-09

    Roasted Peanuts Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling roasted peanuts purchased before May 25, 2023, for undeclared allergen cross-contamination with tree nuts, peanuts, and wheat. The products were sold in Texas and through internet sales.

    Product
    Granulated Peanuts Roasted packaged in 5 pound bags; Virginia Peanuts Roasted NO SALT packaged in 5 pound bags; Spanish Peanuts Roasted & Salted packaged in 5 pound bags;
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2257-2023·2023-08-09

    MEGADYNE Suction Coagulators recalled for fluid ingress causing device malfunction

    Megadyne Medical Products is recalling 241,457 MEGADYNE Suction Coagulators due to fluid ingress into the handpiece, which may cause unintended activation, failure to activate, or self-activation during surgical procedures.

    Product
    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2023·2023-08-09

    VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect

    Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye swelling.

    Product
    VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1352-2023·2023-08-09

    Papa Vic Pizza Dough Recalled for Undeclared Soy Flour

    Cassanos Inc. is recalling Papa Vic Pizza Dough because it may contain undeclared soy flour. The affected product was distributed to nine states.

    Product
    Papa Vic Pizza Dough: packaged as 8in, 12in, 14in, 16in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2253-2023·2023-08-09

    Fusion Lithotripsy Extraction Basket Recalled for Mechanical Failure

    Wilson-Cook Medical is recalling Fusion Lithotripsy Extraction Baskets due to mechanical failures that may prevent proper basket advancement or retraction during biliary stone removal procedures.

    Product
    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1041-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data

    Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1327-2023·2023-08-09

    Toffee Peanuts Recalled for Undeclared Allergens: Tree Nuts and Wheat

    Houston Pecan Company recalls Toffee Peanuts in 5-pound bags due to undeclared allergens (tree nuts and wheat) from cross-contamination in products distributed in Texas and online.

    Product
    Toffee Peanuts, Peanuts, Sugar, Salt packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0984-2023·2023-08-09

    IV Oxytocin Solution Recall Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 9,504 IV bags of oxytocin mixed with Lactated Ringer's solution because validation data for sterilization cycles is lacking. The product was distributed nationwide.

    Product
    oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1354-2023·2023-08-09

    San Marco Premium Dough recalled for undeclared soy flour allergen

    Cassanos Inc is recalling San Marco Premium Dough on Parchment due to undeclared soy flour. Consumers with soy allergies who consume this product face allergic reaction risk.

    Product
    San Marco Premium Dough on Parchment: packaged as 8in, 14in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1050-2023·2023-08-09

    Fentanyl Injectable Solution Recalled for Unvalidated Sterilization Cycles

    Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2023·2023-08-09

    Medline Procedural Kits with Ultrasound Gel Recalled for Sterility Risk

    Medline is recalling 3,431 procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Numb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1073-2023·2023-08-09

    ePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps

    Central Admixture Pharmacy Services is recalling 8,942 ePHEDrine syringes nationwide due to lack of validation data for sterilization procedures, creating a potential sterility risk for injectable medications.

    Product
    ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2023·2023-08-09

    Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards

    Medline is recalling 1,130 custom sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0989-2023·2023-08-09

    FDA Recalls IV Potassium Phosphate Solution Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 7,469 bags of potassium phosphate IV solution nationwide because decontamination validation data is lacking, creating a sterility assurance gap.

    Product
    potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
    Category
    Drug
    Distribution
    Distributed nationwide