FDA Drugs recall ·
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener… recall
- Recall number
- D-0025-2025
- Date
- (initiated October 15, 2024)
- Company / brand
- Akron Pharma, Inc.
373 Us Highway 46 Ste 117, Fairfield, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10845 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
Distribution
Nationwide in the US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0025-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.