Docusate Sodium 250 mg recalled over manufacturing violations
- Recall date
- November 11, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Safecor Health, LLC recalls Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-…
- Recall number
- D-0060-2025
- FDA classification
- Class II
- Brand / firm
- Safecor Health, LLC
- Sold / distributed
- USA nationwide.
Why it was recalled
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
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