Hazard
261 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 261 out of specification recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all out of specification recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (ANGIO PACK-LF) due to higher-than-expected endotoxin levels that may exceed specifications.
Cytal Wound Matrix 2-Layer 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 452 units are affected.
React Health is recalling two PHOENIX 5L Oxygen Concentrators that did not meet internal quality specifications but were inadvertently distributed.
Skin Script Blemish Spot Treatment containing 1% salicylic acid is being recalled after it failed stability specifications. The action covers 28,163 bottles.
Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.
Cytal Burn Matrix 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 226 units are affected.
Cytal Wound Matrix 2-Layer 7x10 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 46 units are affected.
Cytal Wound Matrix 2-Layer 5x5 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 148 units are affected.
Taro is recalling one lot of Fluocinonide 0.05% Cream in 30 g tubes after stability testing returned viscosity results above the specification limit. 41,712 tubes are affected.
Taro is recalling one lot of Fluocinonide 0.05% Cream in 60 g tubes after stability testing returned viscosity results above the specification limit. 2,640 tubes are affected.
Taro is recalling one lot of Fluocinonide 0.05% Cream after stability testing returned out-of-specification viscosity results above the specification limit. 24,672 tubes are affected.
Amneal Pharmaceuticals is recalling two lots of Tramadol Hydrochloride Tablets 50 mg after a nitrosamine impurity was found out of specification at the 24-month stability interval.
Orthalign is recalling one lot of the Trimax Pegged Drill Plate sizes 1-5 for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.
Macleods Pharma USA is recalling one lot of Levothyroxine Sodium Tablets USP 150 mcg because the product is subpotent.
Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.
Amerisource Health Services is recalling one lot of Meclizine Hydrochloride Tablets USP 12.5 mg because the product failed tablet specifications.
Somerset Therapeutics is recalling one lot of Dexamethasone Sodium Phosphate Injection after out-of-specification impurity results at product expiry during long term stability testing.
Aesculap is recalling MINOP Trocar 150 mm with 6.0 mm working channel, model FF399R, because of the potential for the trocar shaft to be too long.
Mylan Pharmaceuticals is recalling two lots of Amnesteem (Isotretinoin) Capsules 40 mg after the product failed dissolution specifications.
Rising Pharma Holding is recalling one lot of Temozolomide Capsules 5 mg after an out-of-specification result was observed during nine-month long-term stability testing.
AvKARE is recalling one lot of Amantadine HCl 100 mg capsules after an out-of-specification finding in dissolution testing.
Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.
Sun Pharmaceutical Industries is recalling a lot of Diclofenac Sodium Topical Gel, 3%, after an out of specification viscosity result slightly below the limit.
Sato Pharmaceutical is recalling 3,640 bottles of INON ACE Antacid tablets after the lot failed disintegration specifications, taking longer than expected.
Novadoz Pharmaceuticals is recalling three lots of Glycopyrrolate Oral Solution, 1 mg/5 mL, after they failed impurities and degradation specifications.