Hazard
36 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 36 assay failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (25%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all assay failure 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.
Sun Pharmaceutical Industries is recalling Clindamycin Phosphate Topical Solution 1% after out of specification results for total impurities and for assay.
Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.
A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.
Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.
Levothyroxine Sodium Tablets, USP 150 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,921 bottles affected.
Levothyroxine Sodium Tablets, USP 50 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 54,227 bottles affected.
Levothyroxine Sodium Tablets, USP 175 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 2,344 bottles affected.
Levothyroxine Sodium Tablets, USP 112 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,896 bottles affected.
Levothyroxine Sodium Tablets, USP 100 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 9,739 bottles affected.
Levothyroxine Sodium Tablets, USP 25 mcg in 1000-count bottles from Accord Healthcare are being recalled because the product is subpotent. 2,352 bottles are affected.
Sun Pharmaceutical is recalling Amphotericin B for Injection (50 mg vials) due to out-of-specification assay results. The recall affects 11,016 vials with lot numbers BAE0055A, BAE0056A, and BAE0068A distributed nationwide.
Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.
Ridge Properties, LLC is recalling PRE-TAT lidocaine gel due to microbial contamination and lidocaine assay issues. Consumers should stop using the product.
Ridge Properties, LLC is recalling Superior Pain & Itch Relief Cream because the product was found to be contaminated and above specification for lidocaine assay.
Ridge Properties, LLC is recalling PRE-TAT Lidocaine Cream due to microbial contamination and lidocaine assay levels above specification. The product was sold nationwide via online retailers.
InvaGen Pharmaceuticals is recalling one lot of Amlodipine Besylate 10 mg tablets because the product failed to meet assay specifications at 3-month stability conditions.
Mayne Pharma is recalling 3,312 cans of Fabior (tazarotene) Foam, 0.1%, because stability testing showed high out-of-specification results for the active ingredient.
Llorens Pharmaceutical Corp. is recalling Urin D/S Tablets because FDA analysis found the product to be out of specification for assay, resulting in subpotent or superpotent tablets.
The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg, due to out-of-specification assay results. The recall covers 36,990 tablets distributed nationwide and in Puerto Rico.
Burel Pharmaceuticals is recalling Uramit MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.
Burel Pharmaceuticals is recalling AZUPHEN MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.
Nationwide Laboratories is recalling Salsalate Tablets, 750 mg, because they were manufactured under practices that may result in assay or content uniformity failures.
Nationwide Laboratories is recalling Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.
Nationwide Laboratories is recalling Salsalate Tablets, USP, 500 mg, because they were manufactured under practices that may result in assay or content uniformity failures.
Burel Pharmaceuticals is recalling specific lots of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.