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Hi-Tech Pharmaceuticals Pine Bark Supplements Recalled for Unapproved Drug Claims and Misbranding (H

Hi-Tech Pharmaceuticals recalled 85,950 units of Pine Bark Supplements for unapproved drug claims and misbranding. The FDA enforcement notice lists Hi-Tech Pharmaceuticals, Inc. of Norcross, GA as the marketer. The recall cites unapproved drug claims and misbranding as the reason. Consumers should stop using the product and contact the company for refund or replacement information.

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

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 C15Cl4 Exp Date 10/26
Sizes
60 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

Pine bark extract supplements are marketed for cardiovascular health and oxidative stress support. Consumers typically buy these as dietary supplements for heart health.

Why This Is Dangerous

The hazard relates to unapproved drug claims and misbranding, which means the product was marketed with drug-like claims not approved by the FDA.

Industry Context

This recall is not part of a broader industry pattern.

Practical Guidance

How to identify if yours is affected

  1. Locate the UPC on the package: 8 11836 02446 3
  2. Check the lot number on the bottle: Lot C15Cl4
  3. Check the expiration date: 10/26
  4. Compare to the recall notice for the specific product details

Where to find product info

FDA recall notice H-0592-2025; Hi-Tech Pharmaceuticals customer support materials

What timeline to expect

Refunds or replacements will be communicated by letter; processing times vary

If the manufacturer is unresponsive

  • Keep records of all contact attempts
  • Escalate to FDA/CPSC if no response after 4–6 weeks
  • Consider legal counsel for unresponsive companies

How to prevent similar issues

  • Verify FDA-approved drug claims before buying dietary supplements
  • Check for third-party certifications (USP)
  • Keep receipts and packaging for returns
  • Avoid products with drug-like claims not approved by FDA

Documentation advice

Save all purchase records, letters, and email correspondence; photograph the product and packaging

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Product Details

Brand: Hi-Tech Pharmaceuticals. Product: Pine Bark Supplements. Form: 60 tablets. UPC: 8 11836 02446 3. Model/Lot: Lot C15Cl4 Exp Date 10/26. Quantity: 85,950 units. Distribution: 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: Hi-Tech Pharmaceuticals, Inc. 6015-B Unity Drive Norcross, GA 30071. Recall date: 2025-08-06. Status: Active.

Reported Incidents

No specific injuries or illnesses are cited in the notice. The recall notes regulatory action based on unapproved drug claims and misbranding rather than reported injuries.

Key Facts

  • 85,950 total units recalled
  • Lot C15Cl4 Exp Date 10/26
  • Distributed to 39 states and territories listed in the notice
  • Recall active as of 2025-09-24

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
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot C15Cl4 Exp Date 10/26
Affected States
Nationwide
Report Date
September 24, 2025
Source Agency
FDA - Food Safety
Recall Status
ACTIVE

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