Diocto Liquid Stool Softener (Harvard Drug Group) – Microbial Contamination (2016)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
The Harvard Drug Group
Lot Codes / Batch Numbers
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, exp 07/17, 20351509, 20351510, exp 10/17, 20351511, 20351512, 20351513, exp 11/17, 20351601, exp 01/18, 20351602, exp 02/18, 20351603, exp 03/18, 20351604, 20351605, exp 04/18
Products Sold
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, exp 07/17, 20351509, 20351510, exp 10/17; 20351511, 20351512, 20351513, exp 11/17; 20351601, exp 01/18; 20351602, exp 02/18; 20351603, exp 03/18; 20351604, 20351605, exp 04/18
The Harvard Drug Group is recalling Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist due to Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026