The last thing you need when in gastrointestinal discomfort is a potentially tainted medication. Here's what to know about this alert for an over-the-counter laxative.
11,000 Bottles Recalled of a Laxative Sold at Walmart and Other Retailers
Published on Oct. 28, 2024
If you’ve ever dealt with constipation, there’s no reason to be embarrassed–and you definitely aren’t alone. It’s one of the most common gastrointestinal complaints, says the Cleveland Clinic, and an average of 2.5 million patients reach out to their doctor about it every year. As an at-home fix, many people take stool-softening laxatives, which can help stimulate the bowel system and keep things regular.
However, a recent recall issued by the U.S. Food and Drug Administration (FDA) says that 10,845 units of a liquid laxative produced by Akron Pharma, Inc. in Fairfield, New Jersey, are now being pulled from shelves and distribution centers nationwide. According to the FDA’s Enforcement Report, the recall affects OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, sold nationwide at various retailers that include Walmart, Amazon, and others.
The reason for the recall was listed as “cGMP deviations,” meaning there was a violation of “Current Good Manufacturing Practice,” or approved manufacturing instructions or procedures. A letter penned by the California State Board of Pharmacy further explains that the affected products include an active pharmaceutical ingredient (API) produced by Badri Vishal Chemical Private Limited, a company that is “under an FDA import alert” due to substandard manufacturing practices.
The compromised products, which were sold in 16 fluid ounce bottles, can be identified by three lot numbers and their corresponding expiration dates. The affected products include:
- Lot number ODS230001A and expiration date of 10/2025
- Lot number ODS230002A and expiration date of 10/2025
- Lot number ODS230003A and expiration date of 11/2025
The recall was initially announced on October 15, 2024, but the FDA issued a new classification on October 24 identifying the product as a Class II risk level. This update indicates that use of the product could cause temporary or reversible adverse health effects, but is unlikely to cause serious or permanent adverse health effects.
A separate “warning letter” was sent from the FDA in 2017 to the India-based Badri Vishal Chemical Private Limited company, detailing a failed inspection that took place in 2016 and “summarizes significant deviations from current good manufacturing practice (CGMP).” There were several notable violations at the time, including failure to validate and monitor the company’s water purification system to ensure that water is of appropriate quality; failure to prepare, review, and approve documents related to the manufacturing of API; failure to verify the suitability of analytical methods; and failure to adequately investigate critical deviations.
Do not consume any products that may be affected by this recall, and consult your doctor if you believe you have experienced possible side effects from taking the recalled laxative. No refund information was included in the FDA’s latest report.
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