Dietary Supplement Quercetin Recalled for Unapproved Drug Claims
Hi-Tech Pharmaceuticals is recalling Quercetin dietary supplements (Lot C1612) due to unapproved drug claims and misbranding.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recalls are typically scored 1 or 2. No illnesses, injuries, or deaths have been reported. The recall addresses regulatory labeling and claim violations rather than a consumer safety hazard.
Plain-English summary
Hi-Tech Pharmaceuticals Inc. is recalling Quercetin dietary supplements (120 tablets, UPC 8 11836 02491 3, Lot C1612 with expiration date 08/27) because the product was marketed with unapproved drug claims and misbranding violations.
The recalled product was distributed to all 50 states as well as Guam and Puerto Rico, with a total of 85,950 units affected. The FDA classified the product as misbranded because it carried claims about strengthening the immune system, supporting respiratory health, and supporting cardiovascular health without FDA approval for such therapeutic claims.
The recalled product
- Product
- HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
- Manufacturer
- Hi-Tech Pharmaceuticals Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- unapproved-drug-claims
- mislabeling
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 (1)
- Lot C1612 Exp Date 08/27
Distribution
Distributed in 50 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- GU
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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