Food, drugs, devices › Sato Pharmaceutical Inc.
Drug recall: Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by
FDA enforcement event 84019 is a drug recall by Sato Pharmaceutical Inc. of Torrance, CA, initiated 1 Oct 2019 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 18 Aug 2020. Initiation: voluntary: firm initiated. Sato Pharmaceutical Inc. has 4 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sato Pharmaceutical Inc., Torrance, CA.
Reason for recall
"Subpotent Drug: Formulated amount of sennosides component is less than labelled claim."
Distribution
"Nationwide in the USA and Guam and Saipan, Northern Mariana Islands"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0303-2020 | 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. | 17,284 bottles | Class III | Terminated | 13 Nov 2019 |
Context
Other enforcement events for Sato Pharmaceutical Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Mar 2026 | Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml con | Food | Class III | 1 |
| 1 Oct 2019 | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. West | Drug | Class III | 4 |
| 16 Feb 2017 | Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceu | Drug | Class II | 3 |
All 4 events for Sato Pharmaceutical Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug: Formulated amount of sennosides component is less than labelled claim."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA and Guam and Saipan, Northern Mariana Islands"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.