Hazard
270 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 270 dissolution 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 10 (4%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all dissolution 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.
Amerisource Health Services is recalling Bupropion Hydrochloride 150mg extended-release tablets nationwide due to dissolution specification failures. The tablets dissolve faster than specified limits.
Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.
The FDA is recalling Venlafaxine Hydrochloride extended-release capsules (37.5mg) distributed nationwide because routine stability testing revealed the capsules failed to meet dissolution specifications, potentially affecting drug effectiveness.
Pacira Pharmaceuticals recalls Zilretta intra-articular injectable suspension nationwide after the product failed dissolution specifications in stability testing.
Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.
Glenmark Pharmaceuticals is recalling 3,264 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to failure to meet dissolution specifications. The affected lot may not release the medication properly in the body.
Esperion is recalling certain NEXLIZET (bempedoic acid and ezetimibe) tablets nationwide because the active ingredient may not dissolve properly, potentially reducing effectiveness.
Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide because dissolution testing found the product does not meet specifications. The FDA has classified this as a Class II recall.
Teva Pharmaceuticals is recalling TRI-LO-SPRINTEC oral contraceptive tablets nationwide due to failed dissolution specifications affecting 92,676 cartons.
Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.
Sun Pharmaceutical is recalling Mesalamine extended-release capsules due to failed dissolution specifications. The affected capsules may not dissolve and release medication properly.
Strides Pharma recalls Methoxsalen 10mg capsules (Lot #7253092B) due to failed dissolution specifications that could reduce medication effectiveness.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
Glenmark Pharmaceuticals is recalling Deferasirox 500mg tablets nationwide due to failed dissolution specifications affecting approximately 5,856 bottles across multiple lots.
Zydus Pharmaceuticals is recalling Oxybutynin extended-release tablets due to failed dissolution testing. The tablets may not dissolve properly, potentially affecting drug efficacy.
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.
Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.
Glenmark Pharmaceuticals is recalling 16,944 bottles of Ranolazine 500mg tablets nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting drug efficacy.
Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.
Zydus Pharmaceuticals recalls Oxybutynin Chloride Extended-Release Tablets 10 mg nationwide because the medication failed dissolution specifications. Affected lot numbers: M300652 and M300651.
Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.
Esperion is recalling Nexlizet (bempedoic acid and ezetimibe) tablets nationwide due to failed dissolution specifications identified during stability testing. Approximately 45,240 bottles are affected.
Ascend Laboratories is recalling 2,652 bottles of Fingolimod capsules nationwide because they failed to meet dissolution specifications, potentially affecting medication effectiveness.
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules (Lot HL00721A, Exp. 12/2023) due to failed dissolution specifications. The extended-release mechanism did not function properly, which could affect medication absorption.