CLASS II ONGOING Drug recall · Reported 30 Oct 2024 · FDA Enforcement Report
OneLAX Docusate Sodium Liquid recalled by Akron Pharma
Akron Pharma is recalling OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/ Stool Softener Laxative, Akron, distributed nationwide in the US. The recall was initiated on 15 Oct 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0025-2025
- FDA event ID
- 95511
- Recalling firm
- Akron Pharma, Fairfield, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Oct 2024
- FDA classified
- 24 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 15 Oct 2024 | Recall initiated by company | |
| 24 Oct 2024 | Classified by FDA | +9 days |
| 30 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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