Wecare Calasoothe recalled over manufacturing violations

Recall date

October 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Blossom Pharmaceuticals recalls Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 1096…

Recall number

D-0213-2026

FDA classification

Class II

Brand / firm

Blossom Pharmaceuticals

Sold / distributed

USA Nationwide

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.