RecallRadar

FDA Drug recall D-0047-2024

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPh…

On 2023-10-25 the FDA classified a Class I recall of Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPh… by Vistapharm, citing microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0047-2024
ClassificationClass I
Statusterminated
Initiated2023-10-18
Published2023-10-25
Last updated2026-09-13 11:52 UTC
CompanyVistapharm
DistributionUS

Product

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

Reason

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

Identifiers

code_infoLot#: 810300, Exp 10/2023

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-0047-2024%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.