Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
USOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Recalling Firm: The Harvard Drug Group LLC
Reason for Recall / Hazard
TranslatedFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Product Description & Identification
TranslatedOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Affected Products
TranslatedOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Additional Source Details
| Field | Value |
|---|---|
| City | Dublin |
| State | OH |
| Openfda › Unii | D87YGH4Z0Q |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 577208 |
| Openfda › Spl id | 6e3a56a7-0197-44b8-a345-996d1555a025 |
| Openfda › Brand name | OMEGA-3-ACID ETHYL ESTERS |
| Openfda › Spl set id | e40d55f2-db9f-4a48-8639-9aa7491e4de5 |
| Openfda › Package ndc | 0904-7495-06 |
| Openfda › Product ndc | 0904-7495 |
| Openfda › Generic name | OMEGA-3-ACID ETHYL ESTERS |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | OMEGA-3-ACID ETHYL ESTERS |
| Openfda › Manufacturer name | Major Pharmaceuticals |
| Openfda › Application number | ANDA215458 |
| Openfda › Original packager product ndc | 70756-423 |
| Event id | 98763 |
| Address 1 | 7000 Cardinal Pl |
| Address 2 | N/A |
| Code info | Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026 |
| Postal code | 43017-1091 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 2,238 5 x 10 unit dose cartons |
| Reason for recall | Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260409 |
| Initial firm notification | Letter |
| Center classification date | 20260424 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only,...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmThe Harvard Drug Group LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA
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🚨 SAFETY ALERT: The Harvard Drug Group LLC - Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06 Check if your household is affected: https://therecallfile.com/recalls/omega-3-acid-ethyl-esters-capsules-usp-1-gram-50-capsules-5-x-10-unit/FDA-D-0493-2026
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