Why it was recalled
CGMP Deviations
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0025-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 15, 2024
- FDA report date
- Oct 30, 2024
- Quantity
- 10845 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akron Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0025-2025, exactly as published.
Show all FDA fields
- City
- Fairfield
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95511
- Address
- 373 Us Highway 46 Ste 117
- Code information
- Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
- Postal code
- 07004-2456
- Report date
- Oct 30, 2024
- Product type
- Drugs
- Recall number
- D-0025-2025
- Classification
- Class II
- Recalling firm
- Akron Pharma, Inc.
- Product quantity
- 10845 bottles
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Oct 15, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2024