← FDA ENFORCEMENT
D-0060-2025Class II

Safecor Health, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Safecor Health, LLC
Product type
Drug
Status
Ongoing
Report date
2024-11-27
Distribution
USA nationwide.
Firm state
MA
Product quantity
587 boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →