Hazard
22 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 22 degradation product recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (9%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all degradation product 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.
Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.
Teva Pharmaceuticals is recalling Pitavastatin 2 mg tablets manufactured by Orient Pharma due to failed impurities and degradation specifications.
Ascend Laboratories is recalling Cephalexin for Oral Suspension due to failed impurity specifications identified during stability testing. An out-of-specification result for Cephalexin Glucose Adduct was observed at six months.
Ascend Laboratories is recalling Cephalexin for Oral Suspension due to an out-of-specification result in impurity testing that identified Cephalexin Glucose Adduct during stability analysis.
Glenmark Pharmaceuticals Inc., USA is recalling Ezetimibe and Simvastatin Tablets (10mg/40mg) due to out-of-specification results for related substances in a stability study. The recall affects approximately 6,759 bottles distributed nationwide.
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium 40 mg delayed-release oral suspension because out-of-specification test results were found for unknown degradation products during stability testing.
Lupin Pharmaceuticals is recalling Clomipramine Hydrochloride Capsules (25 mg) due to an unspecified degradation product detected in stability testing. The defect was identified during an 18-month long-term stability study.
Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.
Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.
Eugia US LLC is recalling 15,500 vials of Eptifibatide injection nationwide due to failed impurities and degradation specifications. The defect involves a related substance identified as Eptifibatide dimer.
Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.
Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.
Apotex Corp. is recalling Paroxetine Hydrochloride 20 mg tablets nationwide due to out-of-specification impurity levels in affected lots. No illnesses have been reported.
AVEVA Drug Delivery Systems recalls Buprenorphine Transdermal System 20 mcg/hour (Lot 51836) nationwide due to degradation product impurity exceeding specification limits during stability testing.
Zydus Pharmaceuticals is recalling certain batches of Colchicine Tablets 0.6 mg because quality testing detected out-of-specification levels of Beta-lumicolchicine impurity. Affected lots were distributed in Arizona, Ohio, and Mississippi.
Golden State Medical Supply Inc. is recalling Rifampin Capsules, 150 mg, due to elevated levels of 1-Methyl-4-Nitrosopiperazine (MNP) exceeding the FDA interim specification limit of 5 ppm. Affected lots are distributed nationwide.
Mylan Pharmaceuticals is recalling injectable Rifampin vials nationwide due to failed impurities and degradation specifications discovered during stability testing.
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.
Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg due to out-of-specification results for a degradation product during commercial stability.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets due to high levels of a degradation product.
Physicians Total Care Inc. is recalling Methylprednisolone Tablets, USP, 4 mg, due to potential failure to meet Impurity C specifications.
Meridian Medical Technologies is recalling 83,400 Diazepam autoinjectors because they contain high levels of carbostyril, a known degradation product.