HIGH

Hi-Tech Pharmaceuticals Fish Oil Recalled Over Unapproved Claims

Hi-Tech Pharmaceuticals recalled 85,950 units of its fish oil soft gels on August 6, 2025, due to unapproved drug claims. The recall affects multiple states across the U.S. Consumers should stop using the product immediately.

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

Product Details

The recalled product is Hi-Tech Pharmaceuticals Fish Oil Heart and Brain Health, EPA/DHA Omega 3 Fatty Acids Soft Gels, UPC 8 11836 02585 9. The recall involves Lot 517120551 with an expiration date of April 30. The product was shipped to various states including California, Texas, and New York.

The Hazard

The recall stems from unapproved drug claims that suggest the product may treat or prevent various medical conditions. Such claims can mislead consumers about the product's effectiveness and safety.

Reported Incidents

No incidents or injuries have been reported in connection with this recall. The FDA classified this recall as Class III, indicating that the potential for harm is minimal.

What to Do

Consumers should not consume the product. Contact Hi-Tech Pharmaceuticals Inc. for refund or replacement information. A notification letter will be sent to all purchasers.

Contact Information

For questions regarding the recall, consumers can contact Hi-Tech Pharmaceuticals, Inc. at 6015-B Unity Drive, Norcross, GA 30071.

Key Facts

  • 85,950 units recalled
  • Unapproved drug claims
  • Affected states include CA, TX, NY
  • Contact for refund or replacement
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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeOmega 3 Fish Oil Soft Gels
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot 517120551 Exp Date 04/30
Affected States
Nationwide
Report Date
September 24, 2025
Source Agency
FDA - Food Safety
Recall Status
ACTIVE
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