Hazard
80 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 80 nitrosamine impurity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 25 (31%) 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 nitrosamine impurity 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.
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.
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, 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 Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to the presence of a nitrosamine drug substance related impurity above proposed interim limits.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules nationwide due to elevated levels of a nitrosamine-related impurity that exceed the FDA's interim safety limit. The affected lots include bottles with expiration dates in April 2027.
Chattem Inc. is recalling Unisom SleepMinis 25 mg diphenhydramine capsules due to detection of nitrosamine impurity above FDA limits. Affected lots are 22L603 (exp. Oct 2025) and 378999 (exp. Feb 2027).
Chattem Inc. is recalling Unisom SleepMelts diphenhydramine HCl 25 mg tablets nationwide due to a nitrosamine impurity detected above FDA's acceptable daily intake limit. Affected lots expire between May 2025 and April 2026.
Glenmark Pharmaceuticals is recalling 70,032 bottles of Atomoxetine Capsules nationwide due to N-Nitroso impurity exceeding FDA recommended limits.
Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.
Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.
Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.
PD-Rx Pharmaceuticals recalls DULoxetine DR 30 mg tablets due to excess nitrosamine impurity above acceptable limits. The affected lots were distributed in Florida, Mississippi, and Wisconsin.
Aurobindo Pharma USA is recalling Nebivolol 2.5 mg tablets nationwide due to manufacturing deviations that resulted in the presence of N-Nitroso Nebivolol, a nitrosamine impurity, above acceptable intake limits.
Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.
Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.
Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.
Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.
Golden State Medical Supply is recalling Duloxetine 30mg capsules nationwide due to contamination with N-nitroso-duloxetine, a nitrosamine impurity above the FDA's proposed safety limit. Affected lots expire January 31, 2025.
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.