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

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

Recall #: D-0022-2017
Affected scope: 153,432 bottles
Initiated: July 15, 2016

Compiled from official public sources by the publisher. · Updated September 2026

The Harvard Drug Group recalled Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bot… - a critical-severity action.

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bot… was recalled by The Harvard Drug Group in October 19, 2016. Reason: Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia. Check the official notice for the remedy. Verify recall #D-0022-2017 with the FDA Drug before acting.

The recall

The Harvard Drug Group issued this critical-severity FDA Drug recall-Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia.

Critical
severity level: Class I
classification: October 19, 2016
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0022-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	D-0022-2017
Date reported	October 19, 2016
Date initiated	July 15, 2016
Recalling firm	The Harvard Drug Group
Firm location	Livonia, MI
Affected scope	153,432 bottles
Distribution	Nationwide

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0022-2017) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by The Harvard Drug Group. Units affected: 153,432 bottles.

Why was this product recalled? ▼

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on October 19, 2016. Severity: Critical. Recall number: D-0022-2017.

Where was the recalled product distributed? ▼

Distribution: Nationwide.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

MERCEDES-BENZ 2017: FUEL SYSTEM, GASOLINE 2016-10-19 La' Trim Plus Dietary Supplement Capsules… 2016-10-19 Oasis Dietary Supplement Capsules, 500 mg… 2016-10-19 Jenesis Dietary Supplement Capsules, 350 … 2016-10-19

Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Paricalcitol Capsules, 1 mcg, packaged in… 2016-10-19 Atropine Sulfate 0.01% in 0.9% Sodium Chl… 2016-10-19 Brilliant Blue G 0.025% in 0.9% Sodium Ch… 2016-10-19 Cefuroxime Sodium 10 mg/mL in 0.9% Sodium… 2016-10-19

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported October 19, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026