Fish Oil Supplement Recalled for Unapproved Drug Claims
Hi-Tech Pharmaceuticals fish oil supplement (85,950 units, Lot 517120551) is recalled for making unapproved drug claims on its label regarding cardiovascular health, joint pain, and cognitive function.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or product contamination. The hazard is purely regulatory—unapproved marketing claims on the label. Per the rubric, Class III recalls are typically scored 1-2, and the absence of any actual product safety concern supports a Low severity rating.
Plain-English summary
Hi-Tech Pharmaceuticals, Inc. is recalling HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS due to unapproved drug claims on the product label.
The product label contains claims that the supplement supports cardiovascular health, may help with joint pain, and may improve cognitive function. Under FDA regulations, these claims cause the product to be regulated as an unapproved drug because they exceed what is permitted for dietary supplement labeling.
A total of 85,950 units with Lot 517120551 (expiration date 04/30) were distributed nationwide to all U.S. states and U.S. territories.
Consumers who have purchased this product should stop using it and dispose of it safely. No illnesses or injuries have been reported related to this product. The manufacturer, Hi-Tech Pharmaceuticals Inc., is responsible for the recall.
The recalled product
- Product
- HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 02585 9 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
- Manufacturer
- Hi-Tech Pharmaceuticals Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- unapproved-drug-claims
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 517120551 Exp Date 04/30
Distribution
Distributed in 50 states:
- 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
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