Pfizer has issued a voluntary recall of three lots of its amlodipine besylate tablets after routine quality testing detected levels of a nitrosamine impurity exceeding acceptable intake limits. The recall affects 5 mg and 10 mg tablets distributed to pharmacies nationwide between January and March 2026.
Nitrosamine impurities are classified as probable human carcinogens at high exposure levels over extended periods. Pfizer emphasized that the short-term risk to patients who have taken the affected medication is low, but advises consumers to check their prescription lot numbers against the recall notice.
Patients taking the affected lots should not abruptly stop their medication but should contact their healthcare provider for a replacement prescription. Pfizer says the contamination was traced to a raw material supplier issue that has since been resolved.
