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 Herpes-G Capsules because they were manufactured outside of current Good Manufacturing Practices (CGMP) controls.
RXQ Compounding LLC is recalling Ascorbic Acid 400 MG/ML Injection Solution because of crystallization. The recall covers all lots within expiry distributed nationwide.
Herbal Doctor Remedies is recalling Detensin 500 mg capsules because they were manufactured outside of current Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Sperm Booster because it was manufactured outside of required Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Stone Purger Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Vertigo Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Philips is recalling 26 Vereos PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Herbal Doctor Remedies is recalling Dragon Pain Balm because it was manufactured outside of current Good Manufacturing Practices controls.
Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Herbal Doctor Remedies is recalling Lung Saver Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Fungo Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
Herbal Doctor Remedies is recalling Awake 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices.
Herbal Doctor Remedies is recalling Thyro-Lo 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Lipidtrol Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Philips is recalling 25 IQon Spectral CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
Herbal Doctor Remedies is recalling Glauco-Catar Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Ortho Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Herbal Doctor Remedies is recalling Smoke End Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Ra Medical Systems is recalling four DABRA Laser units because they failed to calibrate during setup. The devices were distributed in California and Pennsylvania.
Biomet 3i is recalling 49 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.
Herbal Doctor Remedies is recalling Herpes-P 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.