CLASS III Drug recall · Reported 13 Nov 2019 · FDA Enforcement Report
Sankaijo Botanical Laxative (docusate sodium 8.33 mg recalled
Sato Pharmaceutical is recalling Sankaijo Botanical Laxative (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, distributed nationwide in the US. The recall was initiated on 1 Oct 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0303-2020
- FDA event ID
- 84019
- Recalling firm
- Sato Pharmaceutical, Torrance, CA
- Brand
- Sankaijo
- Manufacturer
- Sato Pharmaceutical Co., Ltd.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Oct 2019
- FDA classified
- 7 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 1 Oct 2019 | Recall initiated by company | |
| 7 Nov 2019 | Classified by FDA | +37 days |
| 13 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Questions about this recall
Why was it recalled?
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Which lots are affected?
Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
Where was it sold?
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sato Pharmaceutical
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Yunker(branded) Energy & Health Herbal Supplement with Vitamins recalledYunker | Sato Pharmaceutical | Other | Nationwide |
| Drug | CLASS II | INON ACE Antacid tablets (magnesium aluminosilicate recalledInon Ace | Sato Pharmaceutical | Other | CA, HI |
| Drug | CLASS III | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Wal-dram 2 (meclizine Hydrochloride) recalled by Sato PharmaceuticalWal-dram 2 Quick-dissolving | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide |
Other Docusate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Docusate Sodium 250 mg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Docusate Sodium, 100mg softgels recalled by Rx Pak Division of McKesson | Rx Pak Division of McKesson | Packaging Defects | Nationwide |
| Drug | CLASS I | Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding | US Compounding | Sterility | TX |
| Drug | CLASS II | Docusate Calcium Softgel Capsules, 240 mg recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS II | Docusate Calcium, Capsule, 240 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |