Recalls / Class II

Class IID-0060-2025

Product

Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

Affected lot / code info

Lot# 34A0054, exp. date 05/07/2026

Why it was recalled

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Recalling firm

Firm

Safecor Health, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

317 New Boston St, N/A, Woburn, Massachusetts 01801-6231

Distribution

Quantity

587 boxes

Distribution pattern

USA nationwide.

Timeline

Recall initiated

2024-11-11

FDA classified

2024-11-19

Posted by FDA

2024-11-27

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0060-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.