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.

14026–14050 of 22168

HighFDA (Drugs)·D-1167-2023·2023-09-27
octiq Lubricating Eye Drops Recalled Due to Sterility Assurance Defect
Innovus Pharmaceuticals recalled octiq Lubricating Eye Drops due to lack of assurance of sterility. The affected lot was distributed to accounts in Rhode Island and Colorado.
Product
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1171-2023·2023-09-27
Rasagiline Tablets Recalled Due to Failed Dissolution Specifications
Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.
Product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1153-2023·2023-09-27
TRP Natural Eyes sterile eye drops recalled due to lack of sterility assurance
AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief eye drops due to inability to assure sterility. The recalled lot includes 8,810 units distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.
Category
Drug
Distribution
2 states
HighFDA (Food)·F-1538-2023·2023-09-27
Red Velvet Truffles Recalled for Undeclared Yellow Food Colorants
Fox Confections is recalling 138 packages of F-Bombs Red Velvet Truffles sold in Illinois and Ohio retail locations because they contain undeclared FD&C Yellow #5 and Yellow #6 food colorants, which federal regulations require to be clearly labeled.
Product
F-Bombs Red Velvet Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018049
Category
Food
Distribution
0 states
HighFDA (Food)·F-1536-2023·2023-09-27
F-Bombs Cookies & Cream Truffles recalled for undeclared yellow food dyes
Fox Confections LLC is recalling F-Bombs Cookies & Cream Truffles distributed in Illinois and Ohio due to undeclared FD&C Yellow #5 and Yellow #6 food colorants that may cause allergic reactions in sensitive individuals.
Product
F-Bombs Cookies & Cream Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018025
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-1158-2023·2023-09-27
TRP Natural Eyes Eye Ointment Recalled for Lack of Sterility Assurance
TRP Natural Eyes sterile eye ointment (NDC 17312-165-13, Lot 180001, EXP 01/25) is being recalled due to lack of assured sterility. The product was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2594-2023·2023-09-27
SofTech Wheelchair Cushions Recalled for Defective Battery Overheating Risk
Aquila Corporation is recalling 134 SofTech Pressure-Sensing Wheelchair Cushions with defective battery packs that can overheat, risking property damage and a possible injury. The affected units have been distributed nationwide in the US and internationally to Canada, Sweden, Romania, Australia, and the UK.
Product
SofTech Pressure-Sensing Wheelchair Cushions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1151-2023·2023-09-27
FDA Recalls TRP Natural Eyes Eye Drops Due to Sterility Assurance Issue
The FDA is recalling TRP Natural Eyes Aging Eye Relief eye drops due to lack of assurance of sterility. The affected lot DB001 (expiration 06/24) was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2614-2023·2023-09-27
Abbott Cardiac Defibrillators Recalled for Bluetooth Circuit Component Failure
Abbott recalled certain ICD and CRT-D devices manufactured before April 2022 due to a Bluetooth malfunction from a crystal component defect in the BLE circuit. The malfunction causes loss of Bluetooth communication, and in some cases, excessive power drain affecting battery longevity.
Product
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator:
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1160-2023·2023-09-27
FDA Recalls Eye Ointment Product Due to Sterility Assurance Failure
The FDA is recalling Major LubriFresh PM eye ointment due to lack of assurance of sterility. Approximately 282,564 units were distributed to accounts in Rhode Island and Colorado.
Product
MAJOR LUBRIFRESH PM — MAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM)
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2621-2023·2023-09-27
Smith & Nephew knee implant recall: wrong size in packaging
Smith & Nephew recalled 8 knee implants from a specific lot after finding packages labeled as SIZE 5N contained SIZE 4N implants instead. Patients who received these implants should contact their surgeon immediately.
Product
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Category
Medical Device
Distribution
7 states
HighFDA (Drugs)·D-1176-2023·2023-09-27
Sunscreen Recall: Humanrace Ozone Body Protection Cream Lacks Declared SPF
Humanrace Suncare Ozone Body Protection Cream SPF 30 does not contain the sun protection factor declared on the label. Approximately 2,942 units have been recalled.
Product
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1154-2023·2023-09-27
TRP Natural Eyes sterile eye drops recalled for lack of sterility assurance
TRP Natural Eyes Blur Relief eye drops are being recalled due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1164-2023·2023-09-27
TRP Natural Eyes Red Eye Relief eye drops recalled due to sterility concerns
TRP Natural Eyes Red Eye Relief PF sterile eye drops are being recalled due to lack of assurance of sterility. Approximately 196,442 units distributed to accounts in Rhode Island and Colorado may be affected.
Product
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2603-2023·2023-09-27
Orthopedic knee implant component lacks final sterilization before shipment
Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.
Product
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2615-2023·2023-09-27
Abbott Implantable Defibrillator Devices Recalled for Bluetooth Malfunction
Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.
Product
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary f
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1540-2023·2023-09-27
F-Bombs S'Mores Truffles Recalled for Undeclared Yellow Food Dyes
Fox Confections LLC recalls F-Bombs S'Mores Truffles due to undeclared FD&C Yellow #5 and Yellow #6 food dyes. The product may trigger reactions in individuals sensitive to these colorants.
Product
F-Bombs S'Mores Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018155
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2602-2023·2023-09-27
Stryker ACM System nozzle may disassemble during bone cement mixing
The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.
Product
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2605-2023·2023-09-27
Orthopedic hip stem implant recalled due to sterilization failure
Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.
Product
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
Category
Medical Device
Distribution
26 states
HighFDA (Food)·F-1534-2023·2023-09-27
Chocolate Truffles Recalled for Undeclared Yellow Food Dyes
Fox Confections is recalling F-Bombs Original Truffles due to undeclared Yellow #5 and Yellow #6 food dyes not listed on the label. Consumers with sensitivities to these dyes may be affected.
Product
F-Bombs Original Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018001
Category
Food
Distribution
0 states
HighFDA (Food)·F-1520-2023·2023-09-27
Circle K Honey Roasted Peanuts recalled for undeclared soy and wheat allergens
Mount Franklin Foods is recalling Circle K Honey Roasted Peanuts nationwide due to mislabeling that may result in undeclared soy and/or wheat allergens. Consumers with allergies to these substances should not consume this product.
Product
Circle K Honey Roasted Peanuts, Net Wt 2.5 oz, UPC 194283102596
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1152-2023·2023-09-27
TRP Natural Eyes Sterile Eye Drops Recalled Due to Sterility Assurance
TRP Natural Eyes Allergy Eyes Relief Sterile Eye Drops (NDC 17312-032-15, Lot IY001) are recalled due to lack of assurance of sterility. Approximately 8,747 units distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.
Category
Drug
Distribution
2 states
HighFDA (Food)·F-1518-2023·2023-09-27
Circle K Sweet & Spicy Mix recalled for undeclared soy and wheat allergens
Mount Franklin Foods is recalling Circle K Sweet & Spicy Mix nationwide due to potential undeclared soy and wheat allergens caused by mislabeling. Consumers with soy or wheat allergies should not consume the product.
Product
Circle K Sweet & Spicy Mix, Net Wt 7 oz; UPC 194283104613
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2601-2023·2023-09-27
Stryker ACM System Femoral Nozzle Recall for Potential Disassembly
Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.
Product
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1163-2023·2023-09-27
TRP Natural Eyes Red Eye Relief Recalled for Sterility Failure
TRP Natural Eyes Red Eye Relief sterile eye drops have been recalled due to lack of assurance of sterility. The recall affects 8,868 units distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15.
Category
Drug
Distribution
2 states