Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 65862-0550-90 recalled?

Valsartan and Hydrochlorothiazide · 90 TABLET, FILM COATED in 1 BOTTLE (65862-550-90)

Yes — this exact package was recalled

1 FDA recall names the code 65862-0550-90 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

1 of these recalls is still ongoing.

Active ingredient
Valsartan and Hydrochlorothiazide
Strength
VALSARTAN 320 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1
Form
Tablet, Film Coated
Labeler
Aurobindo Pharma Limited
Type
Drug for Further Processing
Product code
65862-0550

Recalls naming this package

Class II ยท Moderate risk

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg

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.

Ongoing Nitrosamine impurity Aurobindo Pharma USA Inc. NDC 65862-550-90 D-0365-2019

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler