Search Product Recalls

FDAJul 10, 2025Nationwide• A.P. Deauville, LLC

Beauty Power Stick Deodorant (A.P. Deauville) – Quality Control Issue (2025)

CGMP Deviations

FDAJul 10, 2025Nationwide• A.P. Deauville, LLC

Access Thyroglobulin Assay (Beckman Coulter) – Result Inaccuracy (2025)

Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.

Moderate

FDAJul 10, 2025Nationwide• Beckman Coulter, Inc.

BD Pyxis MedBank Mini (CareFusion) – Medication Access Issue (2025)

Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.

High

FDAJul 10, 2025Nationwide• CareFusion 303, Inc.

IDM-MICRO-R (mo-Vis) – Software Timing Error (2025)

Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.

High

FDAJul 10, 2025Nationwide• mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium

Ambu SPUR II (Ambu Inc.) – Manometer Port Blockage (2025)

Potential for the manometer port being blocked rendering the manometer non-functional.

FDAJul 9, 2025Nationwide• Ambu Inc.

Fluorescein 2% Ophth (Boothwyn Pharmacy) – Subpotent Drug (2025)

Subpotent Drug

Class IIILow

Semaglutide Injection 4mL (Boothwyn Pharmacy) – Subpotent Drug (2025)

Subpotent Drug

Empowr 3D Knee Insert (Unknown) – Labeling Error (2025)

Knee implants contain incorrect labeling

FDAJul 9, 2025Nationwide

Microbore Extension Set (B.Braun) – Labeling Inaccuracy (2025)

Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.

FDAJul 9, 2025AZ, CA, CO +29 more• B BRAUN MEDICAL INC

VITROS Chemistry Ca Slides (Ortho-Clinical) – Calibration Error (2025)

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

Moderate

FDAJul 9, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

Tropicamide Ophthalmic Solution (Imprimis NJOF) – Potency Concern (2025)

Sub-Potent Drug: Subpotent assay results during stability testing.

Class IIILow

FDAJul 9, 2025Nationwide• Imprimis NJOF, LLC

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Epinephrine Lidocaine HCL (Imprimis NJOF) – Sub-Potent Drug (2025)

Sub-Potent Drug: Subpotent assay results during stability testing.

FDAJul 9, 2025Nationwide• Imprimis NJOF, LLC

Cinacalcet Tablets 90mg (Strides Pharma) – Failed Dissolution (2025)

Failed Dissolution Specifications.

FDAJul 9, 2025Nationwide• Strides Pharma, Inc.

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Semaglutide Injection (Boothwyn Pharmacy) – Subpotent Drug (2025)

Subpotent Drug

Semaglutide Injection (Boothwyn Pharmacy) – Potency Issue (2025)

Subpotent Drug

Ritz Peanut Butter Cracker Sandwiches (Mondelez) – Undeclared Peanuts (2025)

Undeclared Allergen

Undeclared allergens (Peanut) due to mispackaging

FDAJul 8, 2025AL, AK, AZ +46 more• Mondelez Global Llc

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.