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, PETS
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
- Fish Oil Omega-3 Soft Gels
- Model numbers
- Lot 517120551 Exp Date 04/30
- Sizes
- 90 soft gels per bottle
- 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.
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
Hi-Tech Pharmaceuticals Fish Oil EPA/DHA Omega-3 Soft Gels are marketed as a cardiovascular and cognitive health supplement. Each bottle contains 90 soft gels.
Why This Is Dangerous
Regulators determined the product makes unapproved drug claims. These claims were not reviewed or authorized by the FDA, raising regulatory and safety concerns for consumers.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product to avoid misinformation about health benefits and potential misallocation of funds for an unapproved product.
Practical Guidance
How to identify if yours is affected
- Check the bottle for Lot 517120551 and Exp Date 04/30.
- Verify the product is among the affected lots distributed in the listed states.
- Compare with the recall notice URL for confirmation.
Where to find product info
Review the recall notice on the FDA enforcement page linked in the source.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after verification.
If the manufacturer is unresponsive
- Document all communications with Hi-Tech Pharmaceuticals.
- Escalate to consumer protection agencies if the company is unresponsive.
How to prevent similar issues
- Buy supplements from reputable brands with clear FDA-regulated labeling.
- Verify health claims with official regulatory approvals.
- Keep receipts and packaging until the recall is resolved.
Documentation advice
Keep the bottle, lot number, expiration date, purchase receipt, and all recall communications for records.
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Product Details
Model numbers: Lot 517120551 Exp Date 04/30. Sold across multiple states in the U.S. including 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. Quantity: 85,950 units total. Bottle size: 90 soft gels per bottle. Recall date: 2025-08-06. Distribution: Nationwide in the listed states. Price: Not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 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,
- Unapproved Drug Claims in product labeling
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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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