Valsartan (Diovan) recalls

Valsartan is an ARB blood pressure medication affected by widely reported NDMA-related recalls. We track every FDA enforcement recall involving Valsartan (Diovan) — 50 recalls in our database, including 40 active.

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Recent Valsartan recalls

Class IIActiveAug 4, 2026
Novartis Pharmaceuticals Corporation — Failed Dissolution Specifications
Recall D-0746-2026
Class IIMar 15, 2021
Cardinal Health Inc. — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall D-0461-2021
Class IIActiveDec 31, 2018
Aurobindo Pharma USA Inc. — GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall D-1037-2019
Class IIActiveDec 31, 2018
Aurobindo Pharma USA Inc. — GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall D-1035-2019
Class IIActiveDec 31, 2018
Aurobindo Pharma USA Inc. — CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall D-0362-2019
Class IIActiveDec 31, 2018
Aurobindo Pharma USA Inc. — CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall D-0370-2019
Class IIActiveDec 31, 2018
Aurobindo Pharma USA Inc. — GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall D-1036-2019
Class IIActiveDec 31, 2018
Aurobindo Pharma USA Inc. — CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall D-0361-2019

Showing 8 of 50. See all Valsartan recalls.

What to do if your Valsartan is recalled

Don’t panic — and don’t stop taking it on your own. Suddenly stopping a prescription can be riskier than the recall itself.
Check the details. Recalls often affect specific lots, manufacturers, or strengths — not every bottle of Valsartan.
Talk to your pharmacist or doctor about whether your supply is affected and what to do next.

This page is for information only and isn’t medical advice. Always follow your clinician’s guidance.

Valsartan recall FAQs

How will I know if my Valsartan is recalled?

The FDA publishes recalls, but most never make the news. The reliable way is an automated alert: sign up free and we’ll email you when a Valsartan recall is issued.

Are generic Valsartan recalls common?

Most prescriptions filled in the US are generics, so most recalls involve generic products. A recall doesn’t mean the drug itself is unsafe — it usually affects specific lots or manufacturers.

Is SafeTrack free?

Yes — weekly recall alert digests are free forever, with no credit card required. See pricing.

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