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.
Other recalls by Vistapharm
- Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc.,…
FDA Drug · Class III · 2023-12-06 · Vistapharm - Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#6…
FDA Drug · Class III · 2023-11-15 · Vistapharm - Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPh…
FDA Drug · Class I · 2023-10-25 · Vistapharm - Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689…
FDA Drug · Class II · 2022-11-02 · Vistapharm - Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc
FDA Drug · Class II · 2022-01-26 · Vistapharm
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.