OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative recall
FDA recall D-0025-2025 · initiated Oct 15, 2024
Akron Pharma, Inc. recalled OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati… in Oct 2024 — an FDA Class II recall (D-0025-2025) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10845 bottles
Details
- 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.
- Recalling company
- Akron Pharma, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Oct 15, 2024
- FDA report date
- Oct 30, 2024
Frequently asked
- Was OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati… recalled?
- Akron Pharma, Inc. recalled OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati… in Oct 2024 — an FDA Class II recall (D-0025-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati… recalled?
- Per the FDA enforcement record, the reason for recall D-0025-2025 was: CGMP Deviations
- Is a recalled OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati… are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0025-2025.