Sucralfate Oral Suspension 1g per 10mL — Class II drug recall D-1149-2023
Terminated recall by VistaPharm LLC, reported 2023-09-20, distributed nationwide. Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
| Recall number | D-1149-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm LLC, Largo, FL, United States |
| Recall initiated | 2023-08-30 |
| Classified | 2023-09-11 |
| Reported by FDA | 2023-09-20 |
| Terminated | 2024-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 14,400 bottles |
| Reason classes | potency, specification failure |
| NDC | 66689-0305, 66689-0305-16 |
| Lot numbers | 921100 |
| Expiration dates | 2025-02 |
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 for recall
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1149-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.