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.
Pfizer is recalling 70,704 bottles of Advil PM caplets nationwide because the diphenhydramine citrate content was found to be out of specification.
Biomet 3i, LLC is recalling 704 units of Endobon Xenograft Granules 0.5 ML because individual pieces may have incorrect labels with the wrong batch number.
Pinnacle Biologics is recalling 261 vials of Photofrin (porfimer sodium) because the printed expiration date is incorrect.
Fougera Pharmaceuticals is recalling 493,192 tubes of Triamcinolone Acetonide Cream 0.1% because the end flap incorrectly displays 01% instead of 0.1%.
Ortho-Clinical Diagnostics is recalling VITROS 25-OH Vitamin D Total Calibrators because they may generate negatively biased results. Users must immediately discontinue use of all current lots.
Mylan Institutional, Inc. is recalling 3,252 cartons of Carisoprodol Tablets, USP, 350 mg, because the product failed an impurity or degradation specification.
Steris is recalling VERIFY SixCess 270FP Challenge Packs because the outer shipping package for one lot incorrectly identifies the lot number.
Medefil Incorporated is recalling Heparin I.V. Flush Syringes because the barcodes on the master cartons do not match the printed product codes.
Aaron Industries is recalling Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid due to the presence of a white precipitate, confirmed to be the active ingredient guaifenesin.
Gilead Sciences is recalling specific lots of Atripla tablets because they contain red silicone rubber particulates. The recall covers 39,223 bottles distributed nationwide.
Medtronic Vascular is recalling 191 Everest 20cc Inflation Devices due to an incorrect master label. The devices are sterile, single-use tools used to inflate balloon catheters.
Synthes, Inc. is recalling 12 units of Matrix Mandible Short Threaded Drill Guides because they have a gray band instead of the green band shown in the guide.
Bio-Rad is recalling D-10 Dual Program software due to incorrect cartridge count updates when switching programs.
Bracco Diagnostics Inc is recalling VoLumen Barium Sulfate Suspension because the product failed stability testing for preservative content.
Pfizer is recalling specific bottles of Glucotrol XL tablets because they failed to meet dissolution specifications at the 8-hour stability timepoint.
PACK Pharmaceuticals is recalling Timolol Maleate eye drops due to white solid residue found on the exterior of the bottles.
Forest Pharmaceuticals is recalling Namenda XR sample packs because they failed stability dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.
Forest Pharmaceuticals is recalling 156 bottles of Namenda XR 7 mg capsules because they failed stability dissolution testing. The affected product was distributed nationwide and in Puerto Rico.
PACK Pharmaceuticals is recalling 32,029 bottles of Ofloxacin Ophthalmic Solution because stability samples showed white solid residue on the exterior of the bottles.
PACK Pharmaceuticals is recalling 126 bottles of Ofloxacin Ophthalmic Solution 0.3% because stability samples showed white solid residue on the exterior of the bottles.
Greenstone LLC is recalling 22,529 bottles of Glipizide XL 5 mg tablets because a bulk lot failed a dissolution specification test.
PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of the bottles.
Horiba Medical is recalling ABX PENTRA Urine Control L/H because the target range for the Creatinine assay was updated. The recall affects 531 units distributed in the US and Canada.
PACK Pharmaceuticals is recalling specific lots of Timolol Maleate eye drops because stability samples showed white solid residue on the exterior of the bottles.
PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of bottles.