Medications & Supplements/Prescription Drugs

Sucralfate Oral Suspension Recalled for Potency Issues

Agency Publication Date: September 11, 2023

Summary

VistaPharm LLC has recalled 14,400 bottles of Sucralfate Oral Suspension (1g per 10mL), a prescription medication used to treat stomach ulcers. The recall was initiated because the product may be superpotent or subpotent, meaning it does not meet the required strength specifications. No injuries or incidents have been reported in connection with this recall, which affects 414 mL bottles distributed nationwide to wholesalers and retailers.

Risk

Incorrect potency levels mean the medication may not work as intended to treat medical conditions, or it could potentially cause side effects due to an incorrect dosage of the active ingredient.

What You Should Do

The recalled product is Sucralfate Oral Suspension 1g per 10mL (NDC 66689-305-16) sold in 414 mL bottles and manufactured by VistaPharm, Inc.
Check the label of your bottle for lot number 921100 with an expiration date of 02/2025 to determine if your medication is part of this recall.
If you have health concerns or are currently using this medication, contact your healthcare provider or pharmacist for guidance on your treatment plan.
Return any unused product to the place of purchase for a refund, throw it away, or contact VistaPharm LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report a concern.

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 (414 mL bottle)

Variants: 1g per 10mL, Rx Only

Lot Numbers:

921100 (Exp. 02/2025)

NDC:

66689-305-16

Recall #: D-1149-2023; Manufactured and Distributed by VistaPharm, Inc. Largo, FL 33771

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92916

Status: Resolved

Manufacturer: VistaPharm LLC

Sold By: consignees

Manufactured In: United States

Units Affected: 14,400 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 · 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

The recalled product is Sucralfate Oral Suspension 1g per 10mL (NDC 66689-305-16) sold in 414 mL bottles and manufactured by VistaPharm, Inc.

Check the label of your bottle for lot number 921100 with an expiration date of 02/2025 to determine if your medication is part of this recall.

If you have health concerns or are currently using this medication, contact your healthcare provider or pharmacist for guidance on your treatment plan.

Return any unused product to the place of purchase for a refund, throw it away, or contact VistaPharm LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report a concern.