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.
Lupin Pharmaceuticals is recalling 3,200 bottles of Testosterone Topical Solution because the pump mechanism is not working.
Cook Medical is recalling Celect Platinum Vena Cava Filters to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
AvKARE Inc. is recalling Oxybutynin Chloride Extended-Release Tablets because they failed to meet dissolution specifications.
Boehringer Ingelheim is recalling 112 cartons of Mirapex 1 mg tablets because routine stability testing identified low-weight tablets.
Petra Hygienic Systems is recalling Athleticare Anti-Bacterial Hand Soap because it contains triclosan, an ingredient no longer permitted in over-the-counter antiseptic wash products.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications at a 9-month stability timepoint.
Exactech is recalling 40 Equinoxe Preserve Humeral Stems because they may have been packaged with instructions for a different knee implant.
Prolacta Bioscience is recalling a specific lot of human milk caloric fortifier that was under quarantine and not released for distribution.
Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because impurity levels exceeded specifications. The recall covers 674,628 bottles distributed nationwide and in Puerto Rico.
Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.
ACP Nimble Buyer, Inc. is recalling Mometasone Furoate Cream due to a typographical error in the National Drug Code (NDC) on the label.
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.
Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.
Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.
Valeant Pharmaceuticals is recalling 23,884 bottles of Diltiazem HCl CD capsules because they failed dissolution specifications, potentially affecting drug release.
Dr. Reddy's Laboratories is recalling Esomeprazole Magnesium 40mg capsules because they may contain brown pellets.
Oxalis Labs is recalling 53,358 bottles of Clobetasol Propionate Topical Solution due to defective containers and complaints of leakage.
Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution because the product failed stability specifications for opalescence.
Luminex Corporation is recalling Verigene BC-GP Utility Kits because they were incorrectly labeled with Amplification Tray labels.
Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03% because out-of-specification results were observed for individual and total impurities.
Becton, Dickinson and Company is recalling three BD FACSLyric flow cytometers because they were installed with an unsupported Windows 10 operating system configuration.
Ascension Orthopedics is recalling specific Radial Head Implants because they were packaged with instructions for a different product.
La Canasta Mexican Food Products is recalling specific lots of flour tortillas because packaging ink is contaminating the product.
Riverpoint Medical is recalling 443 units of 18G Brachy Grids because they are labeled with a CE mark despite not being approved in the European Union.
Edwards Lifesciences is recalling 277 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.