Lactulose Solution — Class II drug recall D-1053-2017
Terminated recall by VistaPharm, Inc., reported 2017-08-09, distributed in CA, IL, LA, NH, OH, PA, SC. Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
| Recall number | D-1053-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2017-06-26 |
| Classified | 2017-08-01 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2019-04-03 |
| Distributed | CA, IL, LA, NH, OH, PA, SC |
| Quantity | 9,945 cases |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold, yeast |
| NDC | 66689-0038-01 |
| Lot numbers | 458300, 462600, 471000, 474300 |
| Expiration dates | 2018-07, 2018-09, 2018-10, 2018-11 |
Product
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
Reason for recall
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
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-1053-2017. 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.