Severity
Low
LowClass IIITerminated
FDA Food recall · Reported September 24, 2025
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
Unapproved Drug Claims.
Hi-Tech Pharmaceuticals Inc. recalled HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPO… - a low-severity action.
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPO… was recalled by Hi-Tech Pharmaceuticals Inc. in September 24, 2025. Reason: Unapproved Drug Claims.. Check the official notice for the remedy. Verify recall #H-0589-2025 with the FDA Food before acting.
The recall
Hi-Tech Pharmaceuticals Inc. issued this low-severity FDA Food recall-Unapproved Drug Claims..
- Low
- severity level
- 86K units
- affected scope
- Class III
- classification
- September 24, 2025
- reported
Sourced from official FDA Food enforcement records. Verify recall #H-0589-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #H-0589-2025) was formally reported on September 24, 2025, with the manufacturer initiating the action on August 6, 2025. It is classified under Low severity (Class III), with a current status of Terminated. Hi-Tech Pharmaceuticals Inc. is listed as the recalling firm, operating out of Norcross, GA. Federal records list the affected scope as 85,950 units total.
The documented reason for this recall is: Unapproved Drug Claims. Distribution data in the federal record shows the product reached: Product was shipped to the following 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 2 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category - 25,126 food recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
85,950 units total
Related Recalls
6
2 from same agency
Product description
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
Reason for recall
Unapproved Drug Claims.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | H-0589-2025 |
| Date reported | September 24, 2025 |
| Date initiated | August 6, 2025 |
| Recalling firm | Hi-Tech Pharmaceuticals Inc. |
| Firm location | Norcross, GA |
| Affected scope | 85,950 units total |
| Distribution | Product was shipped to the following 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… |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (H-0589-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hi-Tech Pharmaceuticals Inc.. Units affected: 85,950 units total.
Why was this product recalled? ▼
Unapproved Drug Claims.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on September 24, 2025. Severity: Low. Recall number: H-0589-2025.
Where was the recalled product distributed? ▼
Distribution: Product was shipped to the following 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (H-0589-2025) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported September 24, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.