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FDA Announces Recall of Product Linked to B. cepacia

The Food and Drug Administration (FDA) has alerted health care professionals about a voluntary national recall of liquid docusate sodium that has been linked to Burkholderia cepacia (B. cepacia) infections.

In a July 16 announcement, the FDA said PharmaTech LLC, of Davie, Fla., has voluntarily recalled all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories. The agency has confirmed the product has been contaminated with B. cepacia, a group of bacteria found in soil and water and often resistant to common antibiotics. The bacteria, a threat to individuals with weakened immune systems or chronic lung diseases, has been linked to a five-state outbreak.

PharmaTech issued the voluntary recall, but some reports of contaminated liquid docusate sodium have been linked to products manufactured by other companies.

FDA has joined the Centers for Disease Control and Prevention in recommending that clinicians not use any liquid docusate sodium for any medical purpose. Health care professionals also are urged to report to the FDA any adverse events or quality problems related to docusate sodium solutions.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Michelle Rosenfeld is manager of communications at America's Essential Hospitals.

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