Diocto Liquid — Class I drug recall D-0022-2017
Terminated recall by The Harvard Drug Group, reported 2016-10-19, distributed nationwide. Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
| Recall number | D-0022-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2016-07-15 |
| Classified | 2016-10-12 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 153,432 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 00536-0590-85 |
Product
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
Reason for recall
Microbial contamination of Non-Sterile Products; positive findings of 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-0022-2017. 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.