Recalls / Class II
Class IID-0025-2025
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.
- Affected lot / code info
- Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Akron Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 373 Us Highway 46 Ste 117, N/A, Fairfield, New Jersey 07004-2456
Distribution
- Quantity
- 10845 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-10-15
- FDA classified
- 2024-10-24
- Posted by FDA
- 2024-10-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0025-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.