FDA Recall D-0666-2024

Guru Inc. · Lilburn, GA

Class II Ongoing 687 days on record

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

Product

Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019

Lot / code: Batch # IN-032, Exp 11/30/2027

Reason for recall

Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.

Recall record

Recall number: D-0666-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
Recall initiated: 2024-06-26
Classified by FDA Center: 2024-09-23
FDA published: 2024-10-02
Recalling firm: Guru Inc.
Firm location: Lilburn, GA

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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