Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations
Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries and no specified product safety hazard—only manufacturing practice deviations. This is a voluntary, precautionary recall.
Plain-English summary
Akron Pharma, Inc. is recalling OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottles due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
The recall affects 10,845 bottles distributed nationwide in the United States. The affected lots are: ODS230001A and ODS230002A (expiration date 10/2025), and ODS230003A (expiration date 11/2025). The manufacturer initiated this recall voluntarily on October 15, 2024.
Consumers who have purchased this product should check the lot number on their bottle. If the lot number matches those listed above, the product should not be used. Consumers with questions should contact Akron Pharma, Inc. or their healthcare provider.
The recalled product
- Product
- OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
- Manufacturer
- Akron Pharma, Inc.
- Category
- Drug — Stool Softener / Laxative
- Hazard
- manufacturing-deviation
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 (5)
- Lot #ODS230001A
- ODS230002A
- Exp. 10/2025
- ODS230003A
- Exp. 11/2025.
Distribution
Distributed nationwide across the United States.
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