Drug FDA Class II Ongoing cGMP deviation

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

Safecor Health, LLC Published Nov 27, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Safecor Health, LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Blister Card-Foil Separation · primary

Affected products (1)

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

587 boxes

Lot codes: 34A0054

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

Affected areas

Nationwide

Timeline

Initiated

Nov 11, 2024
Published

Nov 27, 2024

Recall number: D-0060-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.