Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg because a known impurity failed to meet specifications.
Par Pharmaceutical is recalling specific lots of Meclizine Hydrochloride 12.5 mg tablets because they failed impurity specifications.
Baxter is recalling HomeChoice and HomeChoice Pro APD systems due to loud operating sounds. The devices function correctly, but the noise is unacceptable to users.
Stryker Spine is recalling 42 units of Radius Rod to Rod Connectors because the device lacks the required FDA 510(k) clearance.
Villa Radiology Systems LLC is recalling six Owandy Radiology I-MAX Touch 3D X-ray units because they lack required accompanying information documents.
Stryker Sustainability Solutions is recalling 1,202 reprocessed surgical drill bits and blades because packaging was not properly sealed.
CooperSurgical is recalling 144 MILEX Pessary Kits because the outer packaging displays incorrect size prints, although the pessary pouch itself is correctly marked.
Villa Radiology Systems LLC is recalling eight Rotograph EVO 3D X-ray units because accompanying documents are missing, causing non-compliance with FDA regulations.
Breckenridge Pharmaceutical is recalling 595 bottles of Duloxetine 60 mg capsules because one bottle contained a foreign omeprazole 10 mg capsule.
Vintage Pharmaceuticals is recalling specific lots of Ranitidine Syrup because preservative levels failed stability specifications.
Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9, Lot 0954, due to an increase in wash error condition codes.
C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.
Becton, Dickinson and Company is recalling two lots of BD CD3 (SK7) FITC in vitro diagnostic reagents due to an error in the Spanish small text on the label.
Rx PAK is recalling Donnatal tablets because the label incorrectly lists Scopolamine Hydrocodone instead of Scopolamine Hydrobromide.
Ohm Laboratories is recalling CareOne Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Ohm Laboratories is recalling TopCare Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
CVS Pharmacy loratadine tablets are being recalled because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.
Concentric Medical Inc is recalling one Distal Access Catheter that was intended for distribution in Korea but was found at a US location in Kentucky.
Ohm Laboratories is recalling Fred's Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result. The FDA classifies this as a Class III recall.
Ohm Laboratories is recalling Sunmark loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Tribute Pharmaceuticals is recalling specific lots of Fenofibric Acid Tablets because they may contain trace amounts of benzophenone from label varnish.
Ohm Laboratories is recalling Rite Aid Pharmacy loratadine orally disintegrating tablets because they failed an assay test, resulting in a superpotent drug classification.
Tribute Pharmaceuticals is recalling 140,607 bottles of Fenofibric Acid Tablets 105 mg because they may contain trace amounts of benzophenone from label varnish.
Ohm Laboratories is recalling Major loratadine orally disintegrating tablets due to out-of-specification assay results. The recall covers 29,360 boxes distributed nationwide.