Docusate Sodium 250 mg recall
FDA recall D-0060-2025 · initiated Nov 11, 2024
Safecor Health, LLC recalled Docusate Sodium 250 mg in Nov 2024 — an FDA Class II recall (D-0060-2025) because cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 587 boxes
Details
- Product
- Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
- Recalling company
- Safecor Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Nov 11, 2024
- FDA report date
- Nov 27, 2024
Frequently asked
- Was Docusate Sodium 250 mg recalled?
- Safecor Health, LLC recalled Docusate Sodium 250 mg in Nov 2024 — an FDA Class II recall (D-0060-2025) because cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Docusate Sodium 250 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0060-2025 was: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Is a recalled Docusate Sodium 250 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Docusate Sodium 250 mg are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot# 34A0054, exp. date 05/07/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0060-2025.