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-V Balm because it was manufactured outside of required Good Manufacturing Practices 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 Herpes-G Capsules because they were manufactured outside of current Good Manufacturing Practices (CGMP) controls.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.
ASTRA, LLC is recalling one Lidar System for Erosion Flume Application due to incorrect labeling of a Class 1 laser product.
Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to potential contamination with B. cepacia bacteria. The recall is a precautionary measure.
Philips is recalling Ingenuity Core CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Herbal Doctor Remedies is recalling Baby Saver Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Philips is recalling Azurion interventional fluoroscopic X-ray systems because a cold restart may take up to 7 minutes, potentially delaying treatment.
Herbal Doctor Remedies is recalling Pain Stopper 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Cardia Forte 500 mg capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Wise Pharmacy is recalling 8 vials of Papaverine/Phentolamine Injectable due to lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Piramal Critical Care is recalling Gablofen (baclofen injection) due to the presence of an unknown impurity observed during shelf life.
Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.
Lupin Pharmaceuticals is recalling Kaitlib Fe chewable tablets because long-term stability testing showed out-of-specification impurities or degradation.
Agfa N.V. is recalling four DR 800 digital radiography systems because the exposed area of fluoroscopic exams may not match the active detector area.
Wise Pharmacy is recalling Gentamicin Irrigation Solution due to a lack of processing controls. The affected product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling specific lots of compounded Papaverine/Phentolamine/Alprostadil injectable vials due to a lack of processing controls.
Philips is recalling 229 Azurion Interventional Fluoroscopic X-ray Systems because a software defect may cause radiation levels too low for diagnostic images.
Wise Pharmacy is recalling 27 vials of Dexamethasone Sodium Phosphate Injection because of a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Pharma Pac is recalling specific lots of Neomycin Ophthalmic Ointment due to insufficient quality assurance controls in the manufacturing facility.
Major Pharmaceuticals is recalling 828 cartons of Divalproex Sodium Extended-Release Tablets because they were exposed to high humidity during packaging.
NingBo Huize Commodity Co., Ltd. is recalling 20,160 units of Pink Lemonade Scented Antibacterial Hand Gel because stability testing was not conducted.
American Health Packaging is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The affected lot was distributed nationwide.
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Orange Scented Antibacterial Hand Gel because stability testing was not conducted.