Posted from: Tuesday, December 11, 2018 - 05:18 PM - Present

Teva Issues Nationwide Recall of All Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide Tablets within Expiry

November 27, 2018 – Teva Pharmaceuticals has voluntarily recalled all lots of its Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets within expiry due to an impurity detected in the valsartan active pharmaceutical ingredient (API).

Like a number of other angiotensin receptor II blocker (ARB) products recalled through the latter half of 2018, Teva’s recalled amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide tablets contain a “sartan” API contaminated with a probable carcinogen (cancer-causing agent). In this instance, that API is valsartan manufactured at a Mylan plant in India. The impurity is N-nitrosodiethylamine (NDEA), which occurs in small amounts in certain foods, drinking water, air pollution, and industrial processes.

Patients taking the recalled medication should not stop without first consulting a doctor or pharmacist, as doing so could have serious health risks.

Patients who wish to contact Teva with medical-related questions, questions about the recalled products, or reports of an adverse event can call 888-838-2872 (select option 3, then option 4). Teva can also be reached by email at In addition, adverse events can be reported to the FDA through its MedWatch program.

Further information regarding the recall can be found at:

Benecard Central Fill, BeneCard PBF’s mail order pharmacy, does not currently dispense the recalled items, and is notifying a small number of members who may have received the recalled Teva products in 2017 or the first half of 2018.

Last Updated Monday, September 16, 2019 - 08:53 AM.