OneLAX Docusate Sodium Liquid Stool Softener Laxative recalled over manufacturing violations
- Recall date
- October 15, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Akron Pharma, Inc. recalls OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pha…
- Recall number
- D-0025-2025
- FDA classification
- Class II
- Brand / firm
- Akron Pharma, Inc.
- Sold / distributed
- Nationwide in the US
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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