FDA Drug recall D-1149-2023
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm,…
- FDA Drug
- Class II
- terminated
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm,… by Vistapharm, citing superpotent/Subpotent single ingredient Drug: Out of Specification Assay results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1149-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-08-30 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vistapharm |
| Distribution | US |
Product
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
Reason
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Identifiers
| code_info | Lot #: 921100; Exp. 02/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1149-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.