Herbal Dietary Supplement Recalled for Undeclared Pharmaceuticals
Infla-650 Herbal Dietary Supplement is being recalled because it contains undeclared acetaminophen, diclofenac, and phenylbutazone. The product was marketed without FDA approval and poses a risk of drug interactions and adverse effects.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with undeclared pharmaceutical ingredients (acetaminophen, diclofenac, phenylbutazone) in a dietary supplement marketed without approved applications. No illnesses or injuries have been reported, but the hazard presents significant risk due to potential drug interactions and adverse effects from consuming unknown pharmaceuticals.
Plain-English summary
Guru Inc. is recalling Infla-650 Herbal Dietary Supplement (700mg, 60 capsules per pouch) due to the presence of undeclared pharmaceutical ingredients. FDA analysis found the product contains acetaminophen, diclofenac, and phenylbutazone—all present without declaration on the label.
The product was marketed and distributed without an approved New Drug Application (NDA) or Abbreviated NDA (ANDA). Consumers purchasing this dietary supplement would not expect it to contain prescription or over-the-counter drugs, creating a serious risk of unintended drug interactions and adverse health effects.
The recalled product (Batch #IN-032, expiration 11/30/2027, UPC 042535355019) was distributed nationally to U.S. consumers, with retail availability in South Carolina, North Carolina, and Ohio. The product was manufactured in India and distributed by Guru Inc., located in Lilburn, Georgia.
Consumers who have purchased this product should stop using it immediately. Those who have consumed the product and experience any symptoms should consult their healthcare provider. Consumers may return the product to the retailer where it was purchased.
The recalled product
- 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
- Manufacturer
- Guru Inc.
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # IN-032
- Exp 11/30/2027
Distribution
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