HIGHFDA FOOD

Hi-Tech Pharmaceuticals Quercetin Dietary Supplement Recalled for Unapproved Drug Claims and Misbrnd

Hi-Tech Pharmaceuticals recalled 85,950 units of its Quercetin dietary supplement distributed to 40+ states after FDA enforcement found unapproved drug claims and misbranding. The recall, active as of Aug 6, 2025, stems from regulatory concerns rather than a reported health incident. Consumers should stop using the product and contact the company for refunds or replacements.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA FOOD
Recall date
August 6, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
August 6, 2025
Hazard Level
HIGH
Brand
Hi-Tech Pharmaceuticals
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Food Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Hi-Tech Pharmaceuticals
Product type
Dietary Supplement Tablet
Model numbers
Lot C1612 Exp Date 08/27
Sizes
120 tablets
Sold at
Unknown
Where affected
Nationwide

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    August 6, 2025

  2. Reported by FDA FOOD

    September 24, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Unapproved Drug Claims and Misbranded.

What You Should Do

Consumers who have purchased this product should not consume it. Contact Hi-Tech Pharmaceuticals Inc. for refund or replacement information. Notification method: Letter

About This Product

Quercetin dietary supplement marketed to support immune, respiratory, and cardiovascular health. Sold as a dietary supplement.

Why This Is Dangerous

The safety issue relates to unapproved drug claims and misbranding, not a confirmed adverse health effect from consumption in the provided data.

Industry Context

This recall is not part of a broader industry pattern based on available information.

Real-World Impact

Consumers may seek refunds or replacements and should avoid using the product until resolved.

Practical Guidance

How to identify if yours is affected

  1. Check Lot number C1612 on the product packaging.
  2. Verify expiration date 08/27 on the lot.
  3. Look for 120-tablet bottle packaging.

Where to find product info

Label on bottle front or back; FDA recall notice and enforcement report H-0594-2025.

What timeline to expect

Refund or replacement process timeline not specified in data provided.

If the manufacturer is unresponsive

  • Document all contacts with the company.
  • File a complaint with consumer protection if needed.
  • Consider contacting FDA for guidance if there is delay.

How to prevent similar issues

  • Verify regulatory approval and claims before purchasing health supplements.
  • Check for FDA warning letters or enforcement actions before buying.
  • Keep receipts and product packaging until refunds are completed.

Documentation advice

Retain packaging, purchase receipt, and all recall notices for records.

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Product Details

Brand: Hi-Tech Pharmaceuticals. Product: Quercetin Strengthens Immune System Supports Respiratory Health Supports Cardiovascular Health. Size: 120 tablets. UPC: 8 11836 02491 3. Lot: C1612 Exp Date 08/27. Quantity: 85,950 units. Sold/distributed to: 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. Manufacturer address: 6015-B Unity Drive, Norcross, GA 30071. Recall date: 2025-08-06. FDA enforcement report: H-0594-2025.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • States distributed to include CA, FL, NY, TX, PA, etc.
  • Lot C1612 Exp Date 08/27

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTELDERLYPETS
Injury Types
POISONINGOTHER

Product Details

Model Numbers
Lot C1612 Exp Date 08/27
Affected States
Nationwide
Report Date
September 24, 2025
Source Agency
FDA - Food Safety
Recall Status
ACTIVE

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