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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Manufacturer
- Sato Pharmaceutical Inc.
- Category
- Drug — OTC Laxative
- Hazard
- 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
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