The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

9551–9575 of 53039

  • HighFDA (Drugs)·D-0376-2024·2024-03-20

    TRP Blur Relief Eye Drops Recalled Nationwide for Sterility Assurance Failure

    TRP Blur Relief sterile eye drops (Lot #B905) are recalled due to inability to assure product sterility. Approximately 7,248 bottles were distributed nationwide.

    Product
    TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0381-2024·2024-03-20

    TRP Natural Eyes eye drops recalled due to lack of sterility assurance

    TRP Natural Eyes Aging Eye Relief eye drops are being recalled because the manufacturer cannot assure the product meets sterility requirements. The recall affects 19,344 bottles distributed nationwide.

    Product
    TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0382-2024·2024-03-20

    TRP Natural Eyes Pink Eye Relief Eye Drops Recalled for Sterility Concerns

    TRP Natural Eyes Pink Eye Relief sterile eye drops are being recalled due to lack of assurance of sterility. The recall affects 139,656 bottles distributed nationwide.

    Product
    TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0374-2024·2024-03-20

    FDA Recalls Betimol Eye Drops for Sterility and Container Closure Defects

    Thea Pharma is recalling Betimol (timolol) ophthalmic solution nationwide for lack of sterility assurance and compromised container closure. The defects could allow contamination of the eye medication.

    Product
    BETIMOL — BETIMOL (TIMOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0379-2024·2024-03-20

    TRP Eye Strain Relief Eye Drops Recalled Due to Lack of Sterility Assurance

    Optikem International recalls TRP Eye Strain Relief eye drops nationwide due to lack of assurance of sterility. Affected units are 10 mL bottles with Lot E206.

    Product
    TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2024·2024-03-20

    D-Clip Surgical Applier Recalled Due to Failure to Release During Surgery

    A surgical clip applier from Peter Lazic Gmbh has been recalled after a reported failure to release the clip during surgery. The applier remained attached to the clip, potentially posing a safety risk during medical procedures.

    Product
    D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2024·2024-03-20

    Hip Prosthesis Stem Labels Lack Clear Guidance on Size and Type

    A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.

    Product
    SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2024·2024-03-20

    D-Clip Applier Recalled for Failure to Release During Surgery

    Peter Lazic GmbH's D-Clip Standard/Mini Applier is being recalled after a customer complaint that the device failed to release the clip during surgery, with the applier remaining attached to the clip.

    Product
    D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0375-2024·2024-03-20

    TRP Natural Eyes Allergy Relief Eye Drops Recalled for Sterility Assurance Issues

    Optikem International is recalling TRP Natural Eyes Allergy Eyes Relief eye drops due to lack of assurance of sterility. The recall affects 30,240 bottles distributed nationwide.

    Product
    TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1057-2024·2024-03-20

    CK Egg Salad Sandwich Recall for Potential Sesame Cross-Contact

    Capitol Commissary LLC recalled CK Egg Salad Sandwich due to potential sesame cross-contact. Affected units were distributed in seven western U.S. states; consumers should not eat the product.

    Product
    CK Egg Salad Sandwich, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983644000097.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1291-2024·2024-03-20

    CLEARLINK Solution Set Adapter recalled for potential drip chamber leaks

    Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.

    Product
    CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0370-2024·2024-03-20

    Potassium Chloride Injection Recalled Due to Pinhole Container Defects

    B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1062-2024·2024-03-20

    Vitony Bakery Cheese-Guava Cake Recalled for Undeclared Yellow Dye Allergens

    Vitony Bakery is recalling Bizcocho de Queso y Guayaba cheese-guava cake for undeclared FD&C Yellow #5 and Yellow #6 dyes. About 6,706 units were distributed in Puerto Rico.

    Product
    Vitony Bakery, Bizcocho de Queso y Guayaba (cheese-guava cake), PESO NETO 14oz (397g) (12 (14 oz) packages per case)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0385-2024·2024-03-20

    Antibiotic Injection Recalled for Failed Stability Specification

    Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.

    Product
    TOBRAMYCIN — TOBRAMYCIN (TOBRAMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2024·2024-03-20

    STERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk

    Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.

    Product
    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0383-2024·2024-03-20

    TRP Natural Eyes Red Eye Relief eye drops recalled for sterility concerns

    The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.

    Product
    TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1067-2024·2024-03-20

    KALO Chocolate Cake Recalled Due to Undeclared Soy Allergen

    KALO Chocolate Cake packages contain carrot cake with undeclared soy not listed on the label. Consumers with soy allergies are at risk of allergic reaction.

    Product
    KALO Chocolate Cake All Natural Gluten Free Serving size one slice (6 oz/177g) CONTAINS MILK, EGG UPC 8 53407 00418 4 Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0372-2024·2024-03-20

    Infuvite Adult Multiple Vitamins Injection Recalled for Storage Deviation

    Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.

    Product
    Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0373-2024·2024-03-20

    Pfizer Bicillin L-A Prefilled Syringes Recalled for Improper Storage

    Mckesson is recalling Bicillin L-A prefilled syringes stored outside label specifications. The FDA Class II recall affects 70 vials distributed to direct accounts in NM, AZ, and UT.

    Product
    Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1290-2024·2024-03-20

    CARTO VIZIGO Guiding Sheath Recalled for Manufacturing Validation Issue

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.

    Product
    CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1059-2024·2024-03-20

    Ready-to-Eat Chicken Salad Sandwich Recalled for Potential Sesame Cross-Contact

    Capitol Commissary LLC is recalling CK Chicken Salad On A Croissant due to potential cross-contact with sesame. The recall affects 29 units distributed across seven Western states.

    Product
    CK Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983644100032.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1058-2024·2024-03-20

    Jacksons Egg Salad sandwiches recalled for potential sesame allergen cross contact

    Capitol Commissary LLC is recalling 1,195 units of Jacksons Egg Salad sandwiches due to potential cross contact with sesame. Consumers with sesame allergies should not consume the affected product.

    Product
    Jacksons Egg Salad, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983642540991.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0384-2024·2024-03-20

    FDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue

    Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0368-2024·2024-03-20

    Prescription drug Febuxostat recalled due to manufacturing contamination

    Sun Pharmaceutical is recalling 47,520 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination found in manufacturing equipment. The FDA classified this as a Class II recall; no illnesses have been reported.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0378-2024·2024-03-20

    TRP Natural Eyes Dryness Relief Eye Drops Recalled for Lack of Sterility Assurance

    Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
    Category
    Drug
    Distribution
    Distributed nationwide