The Recall Desk
LowFDA (Drugs)·D-0303-2020·Announced 2019-11-13

Sato Pharmaceutical Recalls Sankaijo Botanical Laxative Tablets

Sato Pharmaceutical Inc. is recalling Sankaijo Botanical Laxative tablets because the sennosides content is lower than the labeled claim.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The hazard is a subpotent formulation, which is a documentation and quality control issue rather than a direct safety threat like contamination or mislabeling of allergens.

Plain-English summary

Sato Pharmaceutical Inc. is recalling 17,284 bottles of Sankaijo Botanical Laxative (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets. The recall was initiated because the formulated amount of the sennosides component is less than the labeled claim, making the product subpotent.

The affected product is distributed nationwide in the USA, as well as in Guam and Saipan, Northern Mariana Islands. The recall includes 150-count bottles with the following lot numbers and expiration dates: TXWT (Exp 01/20), TXTS (Exp 10/20), and AXWS (Exp 10/21).

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund. The product is manufactured by Sato Pharmaceutical Co., Ltd. in Japan and distributed by Sato Pharmaceutical, Inc. in Torrance, California.

The recalled product

Product
SANKAIJO (DOCUSATE SODIUM, SENNOSIDES)
Brand
SANKAIJO
Affected units
17,284

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #: TXWT
  • Exp 01/20
  • TXTS
  • Exp 10/20
  • AXWS
  • Exp 10/21

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically: