Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MI...

FDA Recall #D-0203-2026 — Class II — October 31, 2025

Recall #D-0203-2026 Date: October 31, 2025 Classification: Class II Status: Ongoing

Product Description

Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

Reason for Recall

cGMP deviations

Recalling Firm

Blossom Pharmaceuticals — Bardej, Goa

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

18912 containers

Distribution

USA Nationwide

Code Information

Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated