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.
Red Bull North America is recalling 1,395 cases of Total Zero Energy Drink because the cans are missing the mandatory phenylalanine warning for individuals with phenylketonuria.
Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.
Northwind Pharmaceuticals is recalling 40 bottles of Prednisone 20 mg tablets because the NDC number on the container is incorrect.
Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.
Lab Vision Corporation is recalling p21 WF1 Ab-3 antibody vials because the label incorrectly states the concentration as 0.2 mg/ml instead of the actual 0.4 mg/ml.
Biochemical Diagnostics Inc. is recalling CONSULT hCG Controls Kits because storage temperature instructions on the kit labels do not match the vial labels and package insert.
Akorn, Inc. is recalling 13,896 bottles of Hydrocortisone and Acetic Acid Otic Solution because the bottles are missing the safety seal around the neck.
Par Pharmaceutical is recalling specific lots of Meclizine Hydrochloride 12.5 mg tablets because they failed impurity specifications.
Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg because a known impurity failed to meet 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 Sustainability Solutions is recalling 1,202 reprocessed surgical drill bits and blades because packaging was not properly sealed.
Villa Radiology Systems LLC is recalling six Owandy Radiology I-MAX Touch 3D X-ray units because they lack required accompanying information documents.
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 eight Rotograph EVO 3D X-ray units because accompanying documents are missing, causing non-compliance with FDA regulations.
CooperSurgical is recalling 144 MILEX Pessary Kits because the outer packaging displays incorrect size prints, although the pessary pouch itself is correctly marked.
Breckenridge Pharmaceutical is recalling 595 bottles of Duloxetine 60 mg capsules because one bottle contained a foreign omeprazole 10 mg capsule.
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.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9, Lot 0954, due to an increase in wash error condition codes.
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.
Vintage Pharmaceuticals is recalling specific lots of Ranitidine Syrup because preservative levels failed stability specifications.
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 Major loratadine orally disintegrating tablets due to out-of-specification assay results. The recall covers 29,360 boxes distributed nationwide.
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 Rite Aid Pharmacy loratadine orally disintegrating tablets because they failed an assay test, resulting in a superpotent drug classification.