Class II · Moderate risk Ongoing
Docusate Sodium 250 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Sankaijo BOTANICAL LAXATIVE
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
What was recalled
Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.
- Recalling firm
- Sato Pharmaceutical Inc.
- NDC code
- 49873-404-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0303-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Docusate recalls
See all
Class II · Moderate risk Ongoing
OneLAX Docusate Sodium Liquid
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Docu Liquid
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Preferred Plus Dioctyl Liquid Stool Softener
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Gericare Diocto Liquid Docusate Sodium Stool Softener
Reason cGMP Deviations: Products may have microbial contamination.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.