VistaPharm Sucralfate Oral Suspension Recall: Drug Assay Results Out of Specification

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Contact the company & request your remedy

Recalling firmVistaPharm LLC7265 Ulmerton Rd · Largo, FL 33771-4809

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

VistaPharm is recalling prescription sucralfate oral suspension because lab tests showed the drug concentration is outside acceptable levels. This could mean the medication isn't working properly for patients.

Why it’s dangerous

The drug's concentration in the suspension is outside the manufacturer's specified range. This could lead to the medication being too weak or too strong, but it does not cause immediate harm or injury in normal use.

Who’s affected

Prescription patients who received this specific sucralfate suspension bottle (414mL) from VistaPharm. Those with the NDC code 66689-305-16 are most at risk.

How to tell if you have this one

Check for the 414mL bottle labeled 'Sucralfate Oral Suspension 1g per 10mL, Rx Only'. The NDC code 66689-305-16 and lot number 921100 are specific identifiers for this recall.

Brand
VistaPharm
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Medication Details
Look for the NDC code 66689-305-16 and lot number 921100 on the bottle label.

✎ GovInfoNow

Questions people ask

Is this medication safe to use?

The recall is due to assay results being out of specification, but the medication does not cause immediate harm. Patients should contact their doctor for guidance.

How do I know if I have the recalled product?

Check for the 414mL bottle with NDC code 66689-305-16 and lot number 921100.

What should I do if I have this product?

The recall does not specify a remedy, so contact your doctor or pharmacist for advice.

Take action

Contact VistaPharm

We’ve drafted a message you can send VistaPharm to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-1149-2023 — VistaPharm VistaPharm

Hello,

I own a VistaPharm that is covered by recall D-1149-2023 from VistaPharm.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1149-2023 (August 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1149-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

VistaPharm LLC recalls Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and

Lower-risk recall