Medications & Supplements/Prescription Drugs

VistaPharm Sucralfate Oral Suspension Recalled for Bacillus cereus

Agency Publication Date: October 17, 2023

Summary

VistaPharm LLC has recalled 180 bottles of Sucralfate Oral Suspension (1g per 10mL), a prescription medication used to treat ulcers, due to contamination with Bacillus cereus bacteria. The recall affects 16 oz (414 mL) plastic bottles distributed nationwide. No incidents or injuries have been reported to date in connection with this issue.

Risk

The product is contaminated with Bacillus cereus, a bacterium that can cause gastrointestinal distress or serious infections, particularly in patients with compromised immune systems.

What You Should Do

This recall affects VistaPharm Sucralfate Oral Suspension (1g per 10mL) packaged in 16 oz (414 mL) bottles with NDC 66689-305-16, lot number 810300, and an expiration date of 10/2023.
If you have health concerns after using this medication, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact VistaPharm LLC at 1-888-655-1505 for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sucralfate Oral Suspension (16 oz / 414 mL)

Variants: 1g per 10mL

Lot Numbers:

810300 (Exp 10/2023)

NDC:

66689-305-16

Quantity: 180 bottles; Recall #: D-0047-2024

Product Images

Image 1 - Sucralfate Oral Suspension 1g/10mL

Image 2 - Sucralfate Oral Suspension 1g/10mL

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93096

Status: Resolved

Manufacturer: VistaPharm LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 180 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects VistaPharm Sucralfate Oral Suspension (1g per 10mL) packaged in 16 oz (414 mL) bottles with NDC 66689-305-16, lot number 810300, and an expiration date of 10/2023.

If you have health concerns after using this medication, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact VistaPharm LLC at 1-888-655-1505 for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.