Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.

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 inta…

Recall #: D-0368-2019
Affected scope: 32,160 bottles
Initiated: December 31, 2018

Compiled from official public sources by the publisher. · Updated September 2026

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Aurobindo Pharma USA Inc. recalled Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Ma… - a moderate-severity action.

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Ma… was recalled by Aurobindo Pharma USA Inc. in January 23, 2019. Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API u…. Check the official notice for the remedy. Verify recall #D-0368-2019 with the FDA Drug before acting.

The recall

Aurobindo Pharma USA Inc. issued this moderate-severity FDA Drug recall-CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API u….

Moderate
severity level: Class II
classification: January 23, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0368-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.

Reason for recall

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 Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	D-0368-2019
Date reported	January 23, 2019
Date initiated	December 31, 2018
Recalling firm	Aurobindo Pharma USA Inc.
Firm location	East Windsor, NJ
Affected scope	32,160 bottles
Distribution	Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0368-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.. Recalled by Aurobindo Pharma USA Inc.. Units affected: 32,160 bottles.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on January 23, 2019. Severity: Moderate. Recall number: D-0368-2019.

Where was the recalled product distributed? ▼

Distribution: Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Drug, reported January 23, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026