The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0022-2017·Announced 2016-10-19

Diocto Liquid Stool Softener Recalled for Microbial Contamination

The Harvard Drug Group is recalling Diocto Liquid stool softener bottles due to positive findings of Burkholderia cepacia contamination.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text identifies the agency classification as Class I, which corresponds to a Critical severity score per the rubric.

Plain-English summary

The Harvard Drug Group is voluntarily recalling 153,432 bottles of Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative. The product is distributed in one-pint (473 mL) bottles under NDC 0536-0590-85. The recall is being conducted because of microbial contamination, specifically positive findings of Burkholderia cepacia in non-sterile products.

The affected lots were distributed nationwide. The specific lot codes and expiration dates involved in the recall range from September 2016 to April 2018. Consumers should check their bottles for the specific lot codes and expiration dates listed in the official recall notice to determine if they are affected.

Individuals with the affected product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund. The FDA classifies this recall as Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

The recalled product

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
Manufacturer
The Harvard Drug Group
Category
Drug — Laxative
Hazard
Affected units
153,432

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 20351407
  • 20351408
  • exp 09/16
  • 20351409
  • exp 11/16
  • 20351410
  • exp 12/16
  • 20351501
  • 20351502
  • exp 01/17
  • 20351503
  • exp 03/17
  • 20351504
  • exp 04/17
  • 20351505
  • exp 05/17
  • 20351506
  • 20351507
  • exp 06/17
  • 20351508

Distribution

Distributed nationwide across the United States.

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