US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Dec 31, 2018 (8 years ago)

Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

What was recalled

Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90

Recalling firm
Aurobindo Pharma USA Inc.
NDC code
65862-571-90
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1038-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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