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.
Kroger Specialty Pharmacy is recalling Bethkis 300 mg/4 mL ampules due to a lack of processing controls. The affected product was distributed in five states.
Mako Surgical Corporation is recalling 126 Restoris MCK Tibial Baseplates due to incorrect sizing labels. The devices were distributed to facilities in the US and several international countries.
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
Kroger Specialty Pharmacy is recalling Pediasure Liquid Vanilla G+G in several states due to a lack of processing controls.
Bard Peripheral Vascular Inc is recalling 216 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.
Bard Peripheral Vascular Inc is recalling 181 POWERPORT ClearVUE Slim catheters because the included Patient ID Card has incorrect flushing instructions.
Hyphen BioMed is recalling ZYMUTEST HIA MonoStria kits because the package insert incorrectly lists serum and other fluids as valid sample types.
Kroger Specialty Pharmacy is recalling Dexamethasone 4 mg tablets due to a lack of processing controls. The affected products were dispensed in five states.
Kroger Specialty Pharmacy is recalling Cosentyx 150 mg/mL prefilled syringes due to a lack of processing controls. The recall affects specific lots dispensed in five states.
Kroger Specialty Pharmacy is recalling Orkambi 100 mg/125 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Grato Holdings is recalling Peaceful Mountain Nasal Rescue dietary supplements because they are unapproved new drugs based on disease claims.
Kroger Specialty Pharmacy is recalling Prolia 60 mg/1 mL syringes due to a lack of processing controls. The affected units were dispensed in five states.
Kroger Specialty Pharmacy is recalling Cimzia 200 mg/mL PFS Kits due to a lack of processing controls. The affected lots were dispensed in five states.
Siemens Healthcare Diagnostics is recalling IMMULITE CEA assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.
Kroger Specialty Pharmacy is recalling Sutent 50 mg capsules due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Folic Acid assays because biotin interference is not listed in the instructions for use.
Kroger Specialty Pharmacy is recalling Sprycel 80 mg tablets dispensed in five states due to a lack of processing controls.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Allergy specific IgE Universal Kits because biotin interference is not documented in the instructions for use.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling Dimension Vista AST assays because they may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
Munk Pack Inc. is recalling specific lots of Double Dark Chocolate Protein Cookies due to mold growth. Consumers should check their pantry and discard affected products.
Kroger Specialty Pharmacy is recalling Xolair 150 mg SDV due to a lack of processing controls. The affected products were dispensed in five states.
Eastland Food Corporation is recalling Asian Best Tamarind Candy due to lead levels exceeding FDA action levels.
Beckman Coulter is recalling 2,225 iChemVELOCITY Urine Chemistry Systems because incorrect settings may cause false low results or incorrect color reporting.
Kroger Specialty Pharmacy is recalling Temozolomide 250 mg capsules due to a lack of processing controls. The recall affects specific lots dispensed between December 2017 and February 2018.