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.
Herbal Doctor Remedies is recalling Fungo Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Lung Saver Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Sperm Booster because it was manufactured outside of required Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Awake 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices.
Herbal Doctor Remedies is recalling Bone Fixer because it was manufactured outside of required Good Manufacturing Practices controls.
Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.
Herbal Doctor Remedies is recalling Detensin 500 mg capsules because they were manufactured outside of current Good Manufacturing Practice controls.
ASTRA, LLC is recalling one Lidar System for Erosion Flume Application due to incorrect labeling of a Class 1 laser product.
Herbal Doctor Remedies is recalling Baby Saver Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Opternative Inc is recalling the Visibly Online Refractive Vision Test software because it lacks FDA 510(k) clearance. The software was distributed worldwide and in specific US states.
Siemens Healthcare Diagnostics is recalling 815 Dimension Ferritin Flex reagent cartridges due to negative bias. The affected lot is EA9227.
RXQ Compounding LLC is recalling Ascorbic Acid 400 MG/ML Injection Solution because of crystallization. The recall covers all lots within expiry distributed nationwide.
Philips is recalling Ingenuity Core CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Geistlich Pharma is recalling Bio-Oss Pen units because visible green plastic debris was found on the outer barrel when unscrewing the cap.
Herbal Doctor Remedies is recalling Lung Fixer Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Asma Stopper Capsules because they were manufactured outside of current Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Thyro-H 500 mg capsules because they were manufactured outside of current Good Manufacturing Practices controls.
American Health Packaging is recalling 14,360 bottles of Lovastatin 40 mg tablets because the drug substance was out of specification for impurity results.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.
Geistlich Pharma North America is recalling Bio-Oss Pen applicators because a visible piece of green plastic was found on the outer barrel when unscrewing the cap.
Herbal Doctor Remedies is recalling Cardia Forte 500 mg capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Ortho Clinical Diagnostics is recalling 2,531 VITROS 5600 Integrated Systems due to a software anomaly that may cause unsuccessful calibration.
Herbal Doctor Remedies is recalling Yeast Douche Powder because it was manufactured outside of required Good Manufacturing Practices controls.