FDA Recall D-0203-2026

Blossom Pharmaceuticals

Class II Ongoing 195 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

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

Quantity: 18912 containers

Reason for recall

cGMP deviations

Recall record

Recall number: D-0203-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-10-31
Classified by FDA Center: 2025-12-02
FDA published: 2025-12-10
Recalling firm: Blossom Pharmaceuticals

Drug identification

Brand name(s): SALINE ENEMA
Generic name(s): SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC
Manufacturer(s): Dynarex Corporation
NDC(s): 67777-402
Route(s): RECTAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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