Infla-650 Herbal Dietary Supplement recall
FDA recall D-0666-2024 · initiated Jun 26, 2024
Guru Inc. recalled Infla-650 Herbal Dietary Supplement in Jun 2024 — an FDA Class II recall (D-0666-2024) because Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- Guru Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
- Initiated
- Jun 26, 2024
- FDA report date
- Oct 2, 2024
Frequently asked
- Was Infla-650 Herbal Dietary Supplement recalled?
- Guru Inc. recalled Infla-650 Herbal Dietary Supplement in Jun 2024 — an FDA Class II recall (D-0666-2024) because Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Infla-650 Herbal Dietary Supplement recalled?
- Per the FDA enforcement record, the reason for recall D-0666-2024 was: Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
- Is a recalled Infla-650 Herbal Dietary Supplement dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Infla-650 Herbal Dietary Supplement are affected?
- Distributed: Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA. The recall covers these lots — Batch # IN-032, Exp 11/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0666-2024.