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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Sato Pharmaceutical Inc.: Sankaijo Botanical Laxative Recalled for Subpotency

Agency Publication Date: November 7, 2019
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Summary

Sato Pharmaceutical Inc. is recalling 17,284 bottles of Sankaijo BOTANICAL LAXATIVE (docusate sodium and sennosides) because the tablets contain less of the active ingredient sennosides than the label claims. This subpotency means the medication may not work as effectively as intended for its labelled use. Consumers who have purchased these 150-count bottles should check their packaging for specific lot numbers and expiration dates. If you have an affected bottle, you should contact your healthcare provider or pharmacist for guidance on an alternative treatment.

Risk

The formulated amount of the sennosides component is lower than the amount listed on the product label, which can lead to reduced effectiveness of the laxative for the consumer.

What You Should Do

  1. Check your bottle of Sankaijo BOTANICAL LAXATIVE (150-count) to see if it matches NDC 49873-404-01.
  2. Verify if your bottle belongs to one of the following affected lots: TXWT (Expiration 01/20), TXTS (Expiration 10/20), or AXWS (Expiration 10/21).
  3. Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to discuss alternative treatments.
  4. Return any unused product to the place of purchase for a refund and contact Sato Pharmaceutical Inc. at 20695 S. Western Ave., Suite 240, Torrance, CA 90501 for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets (150-count bottles)
Model:
NDC 49873-404-01
Lot Numbers:
TXWT (Exp 01/20)
TXTS (Exp 10/20)
AXWS (Exp 10/21)
Date Ranges: January 2020, October 2020, October 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84019
Status: Resolved
Manufacturer: Sato Pharmaceutical Inc.
Manufactured In: Japan, United States
Units Affected: 17,284 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.