Colace Recall

The FDA has received many reports of adverse events from people who took liquid docusate sodium products and contracted Burkholderia cepacia - a bacterial infection. On July 16th 2016, PharmaTech LLC voluntarily recalled lots of a docusate sodium solution called "Diocto Liquid". The distributer - Rugby Laboratories - stated the medicine was contaminated with B. cepacia and that it was associated with an outbreak in five states. Both the CDC and the FDA recommended that healthcare providers discontinue use of this medication.

Questions & Answers

Side Effects & Adverse Reactions

  • do not use if you are presently taking mineral oil, unless told to do so by a doctor
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
    These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours


There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Colace Manufacturers

  • Physicians Total Care, Inc.
    Colace (Docusate Sodium) Capsule [Physicians Total Care, Inc.]
  • Purdue Products Lp
    Colace (Docusate Sodium) Capsule [Purdue Products Lp]
  • Cardinal Health
    Colace (Docusate Sodium) Capsule [Cardinal Health]

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