FDA Recall D-0166-2025

MXBBB · El Paso, TX

Class II Ongoing 546 days on record

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

Product

UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

Lot / code: Lot#: 24183, Exp 07/01/28

Quantity: 321 bottles

Reason for recall

cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.

Recall record

Recall number: D-0166-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was sold via Amazon Marketplace.
Recall initiated: 2024-11-14
Classified by FDA Center: 2024-12-26
FDA published: 2025-01-01
Recalling firm: MXBBB
Firm location: El Paso, TX

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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