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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 587
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.
Part of a larger recall action
This product is one of 5 recalled by Safecor Health, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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