Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brand
- Hi-Tech Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL, PREGNANT, GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Food Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- Model numbers
- Lot 303120691 Exp Date 05/28
- Sizes
- 30 tablets
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 6, 2025
Reported by FDA FOOD
September 24, 2025
RecallRadar source check
April 18, 2026
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
Adderex XR is marketed as a focus aid supplement sold to adults. It is labeled to enhance concentration and productivity.
Why This Is Dangerous
Regulators determined the product made unapproved drug claims and was misbranded. This creates potential health and regulatory risks for consumers.
Industry Context
This recall is not part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- 1. Locate Lot 303120691 on bottle label
- 2. Confirm Exp Date 05/28
- 3. Compare packaging to recall notice for misbranding warnings
- 4. Do not use if lot matches recall information
Where to find product info
Recall details on FDA enforcement page and the provided recall link
What timeline to expect
Refunds or replacements typically processed after verification, often within 4-6 weeks
If the manufacturer is unresponsive
- Document attempts to contact the company
- File a complaint with the CPSC if necessary
- Consult legal counsel if substantial losses occur
How to prevent similar issues
- Buy from reputable retailers with clear labeling
- Check for FDA-regulated labeling and approved health claims
- Keep packaging intact until recalls are resolved
Documentation advice
Keep bottle, packaging, receipts, and all communications with the company for records
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Product Details
Brand: Hi-Tech Pharmaceuticals. Product: Adderex XR Strongest Focusing Aid. Quantity: 85,950 units. Lot: 303120691. Expiration: 05/28. Form: 30-tablet bottles. Sold/distributed: Nationwide 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: HI-TECH PHARMACEUTICALS, INC., 6015-B Unity Drive, Norcross, GA 30071. Recall number: H-0587-2025. Recall date: 2025-08-06. Status: ACTIVE. Source: FDA enforcement report.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- States/territories reached: AL, AR, AZ, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA,
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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