Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

Recall #: D-1149-2023
Affected scope: 14,400 bottles
Initiated: August 30, 2023

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

VistaPharm LLC recalled Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx … - a moderate-severity action.

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx … was recalled by VistaPharm LLC in September 20, 2023. Reason: Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results. Check the official notice for the remedy. Verify recall #D-1149-2023 with the FDA Drug before acting.

The recall

VistaPharm LLC issued this moderate-severity FDA Drug recall-Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results.

Moderate
severity level: Class II
classification: September 20, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1149-2023 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 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

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

Reason for recall

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

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-1149-2023
Date reported	September 20, 2023
Date initiated	August 30, 2023
Recalling firm	VistaPharm LLC
Firm location	Largo, FL
Affected scope	14,400 bottles
Distribution	Distributed nationwide to 68 consignees in the U.S.

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-1149-2023) 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? ▼

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16. Recalled by VistaPharm LLC. Units affected: 14,400 bottles.

Why was this product recalled? ▼

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on September 20, 2023. Severity: Moderate. Recall number: D-1149-2023.

Where was the recalled product distributed? ▼

Distribution: Distributed nationwide to 68 consignees in the U.S..

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 (Moderate), closest by report date among other firms and states.

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This recall: FDA Drug, reported September 20, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026