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.
Sun Pharmaceutical Industries is recalling one lot of Sulfamethoxazole and Trimethoprim tablets because polyethylene was detected in two tablets.
Perrigo New York is recalling 571,632 tubes of Hydrocortisone Ointment 2.5% because the product failed stability specifications.
Prescript Pharmaceuticals is recalling Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets due to a storage temperature labeling discrepancy.
Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.
ConvaTec is recalling 200 boxes of Esteem Synergy Stomahesive skin barriers because the stoma hole is larger than the 22mm size specified on the label.
L. Perrigo is recalling 569,520 cartons of Scopolamine Transdermal System nationwide due to a defective delivery system.
CooperSurgical is recalling 500 units of the Fischer Cone Biopsy Excisor, Medium, because the products were packaged with an incorrect product size.
Prescript Pharmaceuticals is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because the storage temperature instructions on the label differ from the original manufacturer's declaration.
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.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive may not stick well to the skin.
Kroger Specialty Pharmacy is recalling Polyethylene Glycol 3350 powder for solution due to a lack of processing controls. The product was distributed in five states.
Eastland Food Corporation is recalling Asian Best Tamarind Candy due to lead levels exceeding FDA action levels.
Siemens is recalling the Dimension Vista Creatine Kinase MB assay because it may produce inaccurate results when used with certain drugs.
Kroger Specialty Pharmacy is recalling Dupixent 300 mg/2 mL prefilled syringes due to a lack of processing controls. The recall affects units dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Creon DR 24,000 Units capsules due to a lack of processing controls. The affected products were dispensed in five states.
Michigan Instruments is recalling 38 Thumper Cardiopulmonary Resuscitators because a valve defect may prevent the device from delivering chest compression depth.
Bard Peripheral Vascular Inc is recalling 3,196 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
Bard Peripheral Vascular Inc is recalling 216 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.
Kroger Specialty Pharmacy is recalling Zarxio 300 mcg/0.5 mL PFS due to lack of processing controls. The recall affects specific lots dispensed between December 2017 and February 2018.
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.
American Custom Golf Cars is recalling 2016-2017 ACG Moke low speed vehicles because missing rear side red reflectors reduce visibility to other drivers.
Siemens Healthcare Diagnostics is recalling Dimension AST assays because they may produce inaccurate results when used with certain drugs.
Bard Peripheral Vascular Inc is recalling 835 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
Beckman Coulter is recalling 2,225 iChemVELOCITY Urine Chemistry Systems because incorrect settings may cause false low results or incorrect color reporting.
Munk Pack Inc. is recalling specific lots of Protein Cookies due to mold growth. Consumers should check their pantry and discard affected products.