Diocto Liquid Recall: Microbial Contamination Risk
The Harvard Drug Group recalls Diocto Liquid stool softener due to Burkholderia cepacia contamination. Check lot numbers and expiration dates for affected bottles.
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Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
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What happened, in plain English
The Harvard Drug Group is recalling Diocto Liquid (docusate sodium) 50 mg/5 mL stool softener because it contains microbial contamination, specifically positive findings of Burkholderia cepacia. This Class I recall affects approximately 153,432 bottles distributed nationwide. The record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/42548-diocto-liquid-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42548-diocto-liquid-recall-microbial-contamination-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0022-2017
Cite this page
“Diocto Liquid Recall: Microbial Contamination Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42548-diocto-liquid-recall-microbial-contamination-risk. Based on FDA recall #D-0022-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0022-2017%22&limit=1).
Why it’s dangerous
The product has tested positive for Burkholderia cepacia, a type of microbial contamination found in non-sterile products. Ingesting contaminated liquid stool softeners can pose health risks associated with bacterial presence in medication intended for internal use.
Who’s affected
Consumers who purchased Diocto Liquid stool softener in one-pint (473 mL) bottles distributed by Rugby Laboratories across the United States are affected. Individuals using these specific lots are at risk of exposure to microbial contamination.
How to tell if you have this one
Look for Diocto Liquid (docusate sodium) 50 mg/5 mL in one-pint (473 mL) bottles distributed by Rugby Laboratories. Check the NDC number 0536-0590-85 and specific lot numbers including 20351407, 20351408, 20351409, 20351410, 20351501, 20351502, 20351503, 20351504, 20351505, 20351506, 20351507, 20351508, 20351509, 20351510, 20351511, 20351512, 20351513, 20351601, 20351602, 20351603, and 20351604.
- Brand
Diocto- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Diocto Liquid bottle matches the recalled lot numbers and expiration dates listed in the record.
Stop Using Product
Do not consume the recalled stool softener due to the risk of microbial contamination.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0022-2017 (July 15, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0022-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.