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

OneLAX Stool Softener Liquid Recalled for Manufacturing Process Deviations

Agency Publication Date: October 24, 2024
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Summary

Akron Pharma, Inc. has recalled approximately 10,845 bottles of OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL), a stool softener laxative sold in 16 FL OZ (473 mL) bottles. The recall was issued because the products were manufactured under conditions that deviated from Current Good Manufacturing Practice (CGMP) standards. No injuries or adverse health events have been reported in connection with this recall.

Risk

Deviations from manufacturing standards can result in products that do not meet quality specifications for purity or potency. Using a drug that does not meet these standards may lead to ineffective treatment or unexpected health risks, though the immediate risk of serious injury in this case is considered remote.

What You Should Do

  1. The recalled product is OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, packaged in 16 FL OZ (473 mL) bottles with NDC 71399-0039-06.
  2. Identify affected bottles by checking for lot numbers ODS230001A or ODS230002A with an expiration date of 10/2025, or lot number ODS230003A with an expiration date of 11/2025.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: OneLAX Docusate Sodium Liquid (16 FL OZ / 473 mL)
Variants: 50 mg/5 mL, Liquid
Lot Numbers:
ODS230001A (Exp. 10/2025)
ODS230002A (Exp. 10/2025)
ODS230003A (Exp. 11/2025)
NDC:
71399-0039-06

Manufactured for Akron Pharma, Inc., Fairfield, NJ 07004.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95511
Status: Active
Manufacturer: Akron Pharma, Inc.
Sold By: Retail pharmacies; Drug stores
Manufactured In: United States
Units Affected: 10845 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.