Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
Consumer Product Partners is recalling Hydrogen Peroxide Topical Solution bottles with incorrect back labels indicating 91% Isopropyl Alcohol. The labeling mixup affects 25,932 bottles distributed in Virginia.
USDA FSIS issued a public health alert for Allen Family Foods White Chicken Chili imported from Canada without required reinspection. No illnesses have been reported.
Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.
Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.
Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.
A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.
Ciprofloxacin Ophthalmic Solution is being recalled because the cap spike is lodged in the bottle nozzle, preventing patients from accessing the medication. Affected lot 084A067 was distributed nationwide.
Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.
37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.
Medline Industries has voluntarily recalled over 6.6 million alcohol prep pads nationwide because the product contains less isopropyl alcohol than labeled. The subpotent product was first reported on March 26, 2025.
Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.
Kids by babyganics SPF 50 sunscreen is being recalled due to chemical contamination. Approximately 449,502 units distributed nationwide in the U.S. and Canada are affected in this FDA Class II recall.
GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.
Aspen Biopharma Labs is recalling Bimatoprost due to manufacturing practice deviations. The recall is voluntary and affects product distributed to wholesalers.
Coyote Valley Sour Cream & Onion Chips from Uncle Rays, LLC are being recalled because the product contains more sodium than the label states. Affected products were distributed to customers in Ohio, Nevada, and Texas.
Kowa Pharmaceuticals America is recalling LIVALO (pitavastatin calcium) 4 mg tablets from a specific batch due to the presence of foreign tablets or capsules mixed with the correct medication. No illnesses have been reported.
Aspen Biopharma Labs is voluntarily recalling Voriconazole, an antifungal medication, due to manufacturing process deviations. The product was distributed to three distributors in Hong Kong and Florida.
Black dried beans have been recalled due to elevated levels of fungicide residue. The affected product was distributed to Arizona, California, Idaho, and Oregon.
Aspen Biopharma Labs is recalling finasteride due to manufacturing compliance deviations. The 120 kg voluntary recall was distributed to three distributors in Hong Kong and Florida.
Hiossen recalled ET Rigid and Multi dental abutments for incorrect identification stickers in packaging that misidentify product versions, risking improper placement during installation.
Hiossen has recalled ET Rigid Abutment dental implant components because stickers in the packaging mislabel whether products are Mini or Regular versions. Incorrect identification could affect proper implant installation.
BD BBL TB Stain Kit component shipped with incorrect expiration date labeling. One component has printed expiration 30 September 2024 while Certificate of Analysis indicates 30 April 2025, creating confusion about product validity.
Safecor Health is recalling 3069 units of Ergocalciferol (Vitamin D Supplement) oral syringes nationwide due to leakage in the repackaged unit-dose delivery system. No illnesses have been reported.
Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to patient chart stickers that incorrectly identify the product version. The stickers may identify Mini versions as Regular, or Multi-versions as Mini.