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.
Aniara Diagnostica LLC is recalling 14 kits of BIOPHEN UFH Control C2 because incorrect Instructions for Use were packaged with the product.
Aniara Diagnostica LLC is recalling 41 units of BIOPHEN UFH Control C1 because incorrect versions of the Instructions for Use were packaged into specific lots.
Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4 because incorrect versions of the Instructions for Use were packaged.
AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg due to failed impurities and degradation specifications.
Medi-Physics Inc. dba GE Healthcare is recalling Thallous Chloride TI 201 Injection vials because trace amounts of an impurity were detected in the manufacturing reagent.
Auro Pharmacies Inc. is recalling 167 vials of Biotin 10 mg/mL Injection because the product failed to meet its pH label claim.
Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.
Lupin Pharmaceuticals is recalling 12,504 bottles of Telmisartan and Amlodipine tablets because they failed impurity and degradation specifications in a long-term stability study.
Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.
Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.
Beaver Visitec is recalling 97 boxes of Micro Knife 5.0mm 30° instruments because the expiration date was misprinted as the lot number.
Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurities were detected at the 24-month time point.
Akorn, Inc. is recalling Nystatin Oral Suspension because an unknown impurity was detected during stability testing. The affected product was distributed in Arkansas and Mississippi.
Cypress Medical Products LLC is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests because the packaging is too similar to other products, leading to a denial of CLIA waiver approval.
Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurity levels were detected at the 24-month time point.
Fish House Dressing is recalling 1,741 jars of Jimmy's Original Blue Cheese Salad Dressing because the product may be mislabeled as French Blue Cheese.
Ingenus Pharmaceuticals is recalling 29,435 bottles of Diclofenac Sodium Topical Solution because some bottles were found leaking.
CryoLife, Inc. is recalling two On-X Aortic Heart Valves because they were mislabeled with incorrect serial numbers. The devices were distributed in Georgia and Germany.
Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.
Teva Pharmaceuticals USA is recalling 7,081 bottles of Lansoprazole 15 mg tablets because they contain less than the labeled amount of the active ingredient.
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
Agfa N.V. is recalling specific lots of PET Plates Coated Film-MONOMEDBV2S2 radiographic film because inhomogeneous coating solutions cause visible pinholes in images.
Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
Lupin Pharmaceuticals is recalling 3,200 bottles of Testosterone Topical Solution because the pump mechanism is not working.