
fda regulated Recalls
1,320 recalls tagged with “fda regulated”.

51,320 Belsomra Tablets Recalled for Delayed Dissolution Risk — Check Your Lot Numbers
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Ascend Laboratories Amlodipine and Olmesartan Medoxomil Recall for Low Dissolution 8,568 Bottles in
Failed Dissolution Specifications: low dissolution results
Middlefield Original Cheese Cooperative Cheese Recalled for Listeria Risk (2025)
Potential contamination with Listeria monocytogenes
Summa Therapeutics Recalls 22 Finesse BTK Multicath Angioplasty Balloons Over Burst Specifications (
Potential for the balloon in the device to not meet burst specifications.
DJO Surgical ALTIVATE Glenoid Reamer Head Recall Expands to 927 Units
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
DermaKleen Antiseptic Lotion Soap Recalled Nationwide for Burkholderia cepacia Contamination (Class
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Quest International Measles IgM 01-190M Recall for False Premarket Clearance
Measles IgM Test Kit lacks premarket approval or clearance.
C.R. Bard Recalls 4,300 SureStep Foley Tray System Bardex I.C. Complete Care Catheter Trays (A303316

Deale International Recalls CasaClean Handheld Steamers DF-958 Sold on HSN for Burn Risk (2025)
Deale International is recalling CasaClean Handheld Steamers DF-958 sold on HSN for burn risk. The steamers can leak steam or spray boiling water, creating a serious burn hazard. Consumers should stop using the product and contact Deale for a full refund.
CR Bard Recalls SureStep Foley Tray System A942216 for Incorrect Inserts (2025)

Tractor Supply Recalls Traveller Aluminum Loading Ramps for Fall Hazard (2025)
Tractor Supply recalled three Traveller aluminum loading ramps on July 17, 2025 after determining a fall hazard. The ramps can bend or break under load. Stop using the recalled ramps and seek a full refund from Tractor Supply.
DermaSarra External Analgesic Recalled for Burkholderia Cepecia Contamination (DermaRite Industries)
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Stryker Communications Recalls 40 Medical Light Systems Over Powder Coating Chip Risk (2025)
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

Giant Bicycle Recalls Momentum Vida E+ Electric Bicycles Over Fork Crash Hazard (2025)
Giant Bicycle recalls Momentum Vida E+ electric bicycles after a fork crash hazard. The recall affects bikes with specific serial numbers. Stop riding and contact Giant Bicycle for a fork replacement.
BioFire Defense FilmArray NGDS Warrior Panel NGDS-ASY-0007 Recall 130 Kits in 2025
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Boothwyn Pharmacy Semaglutide 2.5 mg/mL 2 mL Vials Recalled for Subpotent Drug (HIGH)
Boothwyn Pharmacy Semaglutide Injection Recall for Subpotent Drug (4 mL, 2.5 mg/mL)
Boothwyn Pharmacy Fluorescein 2% Ophth 3 mL Recall for Subpotent Drug (High Risk)
Boothwyn Pharmacy recalls 8 vials of Fluorescein 2% Ophth 3 mL nationwide after a subpotent drug finding. The recall was issued July 9, 2025 and remains active.