CLASS II Drug recall · Reported 20 Sep 2023 · FDA Enforcement Report
Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalled
VistaPharm is recalling Sucralfate Oral Suspension per, For Oral Administration Only bottle), distributed nationwide in the US. The recall was initiated on 30 Aug 2023 and the FDA has classified it as Class II.
Check your package
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-1149-2023
- FDA event ID
- 92916
- Recalling firm
- VistaPharm, Largo, FL
- Brand
- Sucralfate
- Manufacturer
- VistaPharm, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Aug 2023
- FDA classified
- 11 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 30 Aug 2023 | Recall initiated by company | |
| 11 Sep 2023 | Classified by FDA | +12 days |
| 20 Sep 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed nationwide to 68 consignees in the U.S.
Questions about this recall
Is Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalled?
Yes. VistaPharm recalled Sucralfate Oral Suspension per, For Oral Administration Only bottle) on 30 Aug 2023. The recall is Class II and its status is Terminated. Recall number D-1149-2023.
Why was it recalled?
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Which lots are affected?
Lot #: 921100; Exp. 02/2025
Where was it sold?
Distributed nationwide to 68 consignees in the U.S.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 |
|---|---|---|---|---|---|
| Drug | CLASS III | Aminocaproic Acid Oral Solution/mL recalled by VistaPharm | VistaPharm | Packaging Defects | Nationwide |
| Drug | CLASS III | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil | VistaPharm | Other | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension 5 mg/mL recalled by VistaPharm | VistaPharm | Potency & Assay | Nationwide |
Other Sucralfate recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sucralfate Tablets recalled by Amerisource Health Services | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sucralfate Tablets recalled by Amerisource Health Services | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sucralfate Tablets recalled by Nostrum Laboratories | Nostrum Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension recalled by DASH Pharmaceuticals | DASH Pharmaceuticals | Packaging Defects | Nationwide |