Hi-Tech Pharmaceuticals recalled 85,950 units of Fish Oil Heart and Brain Health EPA/DHA Omega-3 soft gels distributed nationwide after regulators flagged unapproved drug claims. The FDA enforcement notice identifies unapproved health claims associated with the product. Consumers who bought this product should stop using it and contact Hi-Tech Pharmaceuticals for refunds or replacements.
Unapproved Drug Claims.
Consumers who have purchased this product should not consume it. Contact Hi-Tech Pharmaceuticals Inc. for refund or replacement information. Notification method: Letter
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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.
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.
This recall is not part of a broader industry pattern.
Consumers must stop using the product to avoid misinformation about health benefits and potential misallocation of funds for an unapproved product.
Review the recall notice on the FDA enforcement page linked in the source.
Refunds or replacements are typically processed within 4-8 weeks after verification.
Keep the bottle, lot number, expiration date, purchase receipt, and all recall communications for records.
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.
No injuries or incidents have been reported.
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