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.
Wienke LLC is recalling Wienke's Market Currant Jelly because it contains butter, an ingredient not listed on the label.
McKesson Packaging Services is recalling Megestrol Acetate Oral Suspension because stability testing found the drug was subpotent.
Stevens Family Bakery & Orchard LLC is recalling No Sugar Added Pumpkin Pies because the labels failed to include the required warning statement for aspartame.
Philips is recalling two Ingenuity TF PET/CT systems because one wire channel inside the Gantry Separation Unit was missing mounting hardware.
Wienke LLC is recalling No Sugar Added Apple Butter because it contains butter, an ingredient not listed on the label.
Wienke LLC is recalling Cherry Rhubarb Jam because it contains butter, an ingredient not listed on the label.
Siemens is recalling ADVIA Centaur Calibrator 30 kits because they cause negative bias in Estradiol tests on specific systems.
ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.
Wienke LLC is recalling Wienke's Market Blueberry Rhubarb Jam because it contains butter that is not listed on the label.
Wienke LLC is recalling Wienke's Market No Sugar Added Strawberry Jam because it contains butter, an ingredient not listed on the label.
Empresas Barsan, Inc. is recalling Titan potato puffs in Puerto Rico because the label fails to declare sodium bisulfite as an ingredient.
Philips Medical Systems is recalling Ingenuity Core 128 CT systems due to software issues in version 4.1.6.
Zimmer Biomet is recalling 7,888 Humeral Guide Wire Ball Tip units because the previous packaging configuration lacks design verification for 70cm wires.
Flawless Beauty LLC is voluntarily recalling all lots of Laroscorbine Platinum Vitamin C products because they were marketed without an approved NDA or ANDA.
Millennium Pharmaceuticals is recalling 154,372 vials of VELCADE (bortezomib) for injection due to confirmed reports of loose vial crimps.
Zimmer Biomet is recalling 1,631 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.
Robert Busse & Co. is recalling 5 cases of Safety Deluxe Bone Marrow Biopsy/Aspiration Trays due to the presence of loose polypropylene foreign matter.
Exactech is recalling 34 Alteon HA Femoral Stems because the labels incorrectly described the device. The units were distributed to five US states.
Olde Thompson is recalling Sweet & Smoky BBQ Grinders because the label states 0 mg sodium, but the product contains 350 mg per serving.
Robert Busse & Co. is recalling Safety-Deluxe Basic Soft Tissue Biopsy Trays because they may contain loose polypropylene foreign matter.
Cyberonics, Inc. is recalling two VNS Therapy Programmer units that were distributed in error before FDA approval of the specific software version.
Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems 25 mcg/h because a degradation product exceeded specification limits.
Busse Hospital Disposables is recalling Safety Deluxe Bone Marrow Biopsy/Aspiration Trays because they may contain loose polypropylene foreign matter.
Philips Medical Systems is recalling Ingenuity CT systems due to software issues in version 4.1.6. The recall affects 26 US government accounts.
Zimmer Biomet is recalling 6,290 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.