Pfizer has initiated a voluntary recall of three lots of its amlodipine besylate blood pressure tablets after testing revealed impurity levels exceeding acceptable thresholds. The recall affects 5mg and 10mg tablets distributed to pharmacies across the United States.
The impurity, a nitrosamine compound called NDMA, was found at levels slightly above FDA-established limits. Nitrosamines are classified as probable human carcinogens, though the risk from short-term exposure at the detected levels is considered low.
Approximately 800,000 bottles are affected, distributed between February and April 2026. Patients taking the recalled lots are advised not to stop their medication abruptly but to contact their healthcare provider for an alternative prescription.
Pfizer says the impurity issue has been traced to a raw material supplier and that corrective actions have been implemented. The company is working with the FDA to ensure the quality of future batches.
This recall is part of an ongoing industry-wide challenge with nitrosamine contamination in pharmaceutical products. The FDA has tightened testing requirements for all blood pressure medications following multiple recalls across different manufacturers in recent years.
