Fish oil soft gels recalled over unapproved drug claims on packaging
Hi-Tech Pharmaceuticals Fish Oil, 90 soft gels, lot 517120551, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric puts FDA Class III actions at 1 or 2, and this is a claims and labeling matter with no health hazard described.
Plain-English summary
Hi-Tech Pharmaceuticals Fish Oil with EPA/DHA omega 3 fatty acids, 90 soft gels, UPC 8 11836 02585 9, from Hi-Tech Pharmaceuticals, Inc. of Norcross, Georgia, is being recalled. The affected product is lot 517120551 with an expiry date of 04/30. The recall covers 85,950 units in total, shipped to states across the country.
The recall was issued for unapproved drug claims. The FDA classified the action as Class III.
Customers holding this lot should stop using the product and can return it to the place of purchase.
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
- Food — Dietary Supplement
- Affected units
- 85,950
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
Part of a larger recall action
This product is one of 16 recalled by Hi-Tech Pharmaceuticals Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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