Tejal Somvanshi
If you take a combination blood pressure pill containing both telmisartan and amlodipine, check your bottle — but do not stop taking your medication without speaking to your doctor first.
Viatris has voluntarily recalled 21,620 bottles of telmisartan and amlodipine tablets (40 mg/5 mg) due to a superpotency risk, meaning some tablets may contain higher-than-specified telmisartan levels. The Viatris blood pressure medication recall affects five specific lot numbers: 3228113, 3228114, and 3228115 (expiring October 31, 2026) and 3228120 and 3228121 (expiring November 30, 2026). The National Drug Code is NDC 0378-1075-93. This is an FDA Class III recall — the agency’s lowest risk tier — meaning adverse health consequences are considered unlikely. Viatris initiated the recall at the distributor level on October 1, 2026; it became publicly visible when the FDA published its weekly enforcement report.
Patients taking telmisartan and amlodipine should not stop their medication without first consulting their prescribing physician or pharmacist. If your bottle’s label shows NDC 0378-1075-93 and one of the listed lot numbers, contact your dispensing pharmacy to arrange a replacement lot and follow your healthcare provider’s guidance on continuing treatment.
The recall was triggered by quality control testing showing telmisartan levels exceeded manufacturing specifications in the affected lots — a condition called superpotency. The FDA classifies this as a Class III recall, its lowest tier, because adverse health consequences from the product variation are considered unlikely. Several competing news reports have incorrectly advised patients to stop taking the pill immediately; stopping any prescribed blood pressure medication without medical guidance carries its own risks and should not be done without consulting a doctor.
The recall originated at the wholesale distribution level, which is why most patients were not immediately notified. It became publicly known when the FDA’s weekly retrospective enforcement report was published, weeks after the distributor-level action began. Guides on managing hypertension medications safely and understanding FDA recall classification tiers provide additional context for patients.
Contact your pharmacy now to confirm your lot number. If your prescription matches one of the recalled lots, your pharmacist will arrange an exchange. Follow your doctor’s instructions on continuing your medication until a replacement is secured.
