IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

Presence of Particulate Matter: Product was found to contain silica and iron oxide

Recall #: D-0765-2022
Affected scope: 1565 vials
Initiated: March 29, 2022

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

Teva Pharmaceuticals USA Inc recalled IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single D… - a critical-severity action.

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single D… was recalled by Teva Pharmaceuticals USA Inc in April 20, 2022. Reason: Presence of Particulate Matter: Product was found to contain silica and iron oxide. Check the official notice for the remedy. Verify recall #D-0765-2022 with the FDA Drug before acting.

The recall

Teva Pharmaceuticals USA Inc issued this critical-severity FDA Drug recall-Presence of Particulate Matter: Product was found to contain silica and iron oxide.

Critical
severity level: Class I
classification: April 20, 2022
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0765-2022 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, 6 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 high severity.

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

Product description

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

Reason for recall

Presence of Particulate Matter: Product was found to contain silica and iron oxide

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	D-0765-2022
Date reported	April 20, 2022
Date initiated	March 29, 2022
Recalling firm	Teva Pharmaceuticals USA Inc
Firm location	Parsippany, NJ
Affected scope	1565 vials
Distribution	Nationwide within 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-0765-2022) 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.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 1565 vials.

Why was this product recalled? ▼

Presence of Particulate Matter: Product was found to contain silica and iron oxide

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 20, 2022. Severity: Critical. Recall number: D-0765-2022.

Where was the recalled product distributed? ▼

Distribution: Nationwide within 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

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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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 April 20, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026