CLASS I Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report

Sucralfate Oral Suspension per PET bottle) recalled by VistaPharm

VistaPharm is recalling Sucralfate Oral Suspension per PET bottle), distributed nationwide in the US. The recall was initiated on 18 Oct 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot#: 810300, Exp 10/2023

NDC66689-305

UPC0366689305165

Quantity recalled180 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0047-2024
FDA event ID: 93096
Recalling firm: VistaPharm, Largo, FL
Brand: Sucralfate
Manufacturer: VistaPharm, LLC
Classification: Class I
Status: Terminated
Recall initiated: 18 Oct 2023
FDA classified: 16 Oct 2023
Reported: 25 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Bacterial Contamination

Timeline

16 Oct 2023	Classified by FDA
18 Oct 2023	Recall initiated by company	+2 days
25 Oct 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Product as listed by the FDA

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Which lots are affected?

Lot#: 810300, Exp 10/2023

Where was it sold?

USA Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from VistaPharm

All 36

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023Drug	CLASS III	Aminocaproic Acid Oral Solution/mL recalled by VistaPharm	VistaPharm	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS III	Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil	VistaPharm	Other	Nationwide
20 Sep 2023Drug	CLASS II	Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate	VistaPharm	Potency & Assay	Nationwide
2 Nov 2022Drug	CLASS II	Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide	VistaPharm	Potency & Assay	Nationwide
26 Jan 2022Drug	CLASS II	Clobazam Oral Suspension 2.5 mg/mL recalled by VistaPharm	VistaPharm	Potency & Assay	Nationwide

Other Sucralfate recalls

All 6

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Drug	CLASS II	Sucralfate Tablets recalled by Amerisource Health Services	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
3 Sep 2025Drug	CLASS II	Sucralfate Tablets recalled by Amerisource Health Services	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
6 Aug 2025Drug	CLASS II	Sucralfate Tablets recalled by Nostrum Laboratories	Nostrum Laboratories	Manufacturing (CGMP) Deviations	Nationwide
20 Sep 2023Drug	CLASS II	Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate	VistaPharm	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS II	Sucralfate Oral Suspension recalled by DASH Pharmaceuticals	Dash Pharmaceuticals	Packaging Defects	Nationwide