Hazard
1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 1,552 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 283 (18%) 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 cgmp deviation 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.
Duloxetine Delayed-Release Capsules, USP, 30 mg, lot 240927C, made for Quallent Pharmaceuticals, are recalled because N-nitroso-duloxetine was above the proposed interim limit. 3,591 bottles are affected.
Sucralfate Tablets USP 1 gram from American Health Packaging are recalled because the firm's Chapter 11 filing left it unable to monitor its quality program. 26,992 blister packs are affected.
Carvedilol Tablets USP, 12.5 mg, packaged by Major Pharmaceuticals, lot T05693, are recalled nationwide because N-Nitroso Carvedilol Impurity-1 exceeded the FDA-recommended 4.0 ppm limit. 26,628 cartons are affected.
Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.
Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 bottles affected.
Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.
Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.
Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.
Metoprolol Tartrate Tablets USP, 50 mg, distributed by Westminster Pharmaceuticals, are recalled nationwide after N-nitroso-metoprolol was found above the established Acceptable Daily Intake. 16,672 bottles are affected.
Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.
Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.
Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.
Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.
Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 bottles affected.
Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.
Xolair (omalizumab injection) 75 mg/0.5 mL is being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 4 units affected.
Xolair (omalizumab injection) 150 mg/mL auto-injectors are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 6 units affected.
Recombinate [Antihemophilic Factor (Recombinant)] 5 mL vials are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 3 units affected.
Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.
Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.
Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.
Benlysta (belimumab) for injection 400 mg/20 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 3 vials are affected.
Evenity (romosozumab-aqqg) injection 105 mg/1.17 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 2 pre-filled syringes affected.
Prolia (denosumab) injection 60 mg/mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 6 pre-filled syringes are affected.
Rizatriptan Benzoate Tablets USP 10 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.