Pfizer has initiated a voluntary recall of three lots of its amlodipine besylate 10mg tablets after routine testing detected levels of a nitrosamine impurity exceeding the FDA's acceptable daily intake limit.
Recall Details
The affected lots contain N-nitroso-amlodipine at levels approximately 1.5 times the acceptable threshold. While the health risk from short-term exposure is low, long-term consumption above these levels is associated with a marginal increase in cancer risk.
- Lot numbers: AM10-2509A, AM10-2509B, AM10-2511C
- Distributed to pharmacies nationwide between November 2025 and January 2026
- Approximately 890,000 bottles of 90-count supply affected
Patient Advice
The FDA advises patients not to stop taking their blood pressure medication without consulting their healthcare provider, as the immediate risk of uncontrolled hypertension outweighs the low cancer risk from short-term impurity exposure. Pharmacies should switch affected patients to alternative lot numbers.
