Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative Recalled by The Harvard Drug Group Due to Microbial contamination of Non-Sterile Products; positive findings of...

Date: July 15, 2016
Company: The Harvard Drug Group
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group directly.

Affected Products

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

Quantity: 153,432 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Harvard Drug Group

The Harvard Drug Group has 45 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report