Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40

Presence of foreign substance: One lot of the product may contain black foreign particles

Recall #: D-885-2013
Affected scope: 29,436 bottles
Initiated: June 21, 2013

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

Bracco Diagnostics Inc recalled Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organicall… - a moderate-severity action.

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organicall… was recalled by Bracco Diagnostics Inc in August 21, 2013. Reason: Presence of foreign substance: One lot of the product may contain black foreign particles. Check the official notice for the remedy. Verify recall #D-885-2013 with the FDA Drug before acting.

The recall

Bracco Diagnostics Inc issued this moderate-severity FDA Drug recall-Presence of foreign substance: One lot of the product may contain black foreign particles.

Moderate
severity level: Class II
classification: August 21, 2013
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-885-2013 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

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40

Reason for recall

Presence of foreign substance: One lot of the product may contain black foreign particles

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	Terminated
Recall number	D-885-2013
Date reported	August 21, 2013
Date initiated	June 21, 2013
Recalling firm	Bracco Diagnostics Inc
Firm location	Monroe Township, NJ
Affected scope	29,436 bottles
Distribution	Nationwide

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-885-2013) 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? ▼

Why was this product recalled? ▼

Presence of foreign substance: One lot of the product may contain black foreign particles

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 21, 2013. Severity: Moderate. Recall number: D-885-2013.

Where was the recalled product distributed? ▼

Distribution: Nationwide.

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

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This recall: FDA Drug, reported August 21, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026