Lactulose Solution — Class II drug recall D-0146-2017
Terminated recall by VistaPharm, Inc., reported 2016-11-30, distributed nationwide. Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteri
| Recall number | D-0146-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2016-11-09 |
| Classified | 2016-11-22 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2021-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,497 cases |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 66689-0039-01, 66689-0039-50 |
| Lot numbers | 11/16, 378300 |
Product
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Reason for recall
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
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-0146-2017. 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.