Docusate Sodium 250 mg softgels recalled due to defective blister packaging
Safecor Health is recalling Docusate Sodium 250 mg softgels due to manufacturing defects where blister card-foils separated from the medication cavity, potentially compromising product integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The manufacturing defect (separated blister packaging) creates a risk-of-harm situation by exposing medication to potential contamination, fitting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Safecor Health, LLC is recalling Docusate Sodium 250 mg softgels in 100-count unit dose boxes due to current Good Manufacturing Practice (cGMP) deviations.
The defect involves blister card-foils separating from the blister cavity, which compromises the integrity of the medication packaging and creates a risk of product contamination or degradation. This manufacturing error was identified during manufacturing observations.
The affected product is Lot #34A0054 with an expiration date of 05/07/2026, distributed nationwide in the USA. A total of 587 boxes were distributed under this recall.
Consumers who have received the affected product should stop using it and contact Safecor Health or their healthcare provider for guidance on replacement or alternative medications.
The recalled product
- Product
- Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Oral Medication
- Hazard
- packaging-defect
- potential-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 34A0054
- exp. date 05/07/2026
Distribution
Distributed nationwide across the United States.
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