Drug recall
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx…
FDA recall event 98763 · Class II · The Harvard Drug Group LLC
Key facts
| Event ID | 98763 |
|---|---|
| Recall numbers | D-0493-2026 |
| Recalling firm | The Harvard Drug Group LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. |
| Initiation date | Apr 9, 2026 |
| Report date | Apr 29, 2026 |
| City | Dublin |
| State | OH |
| Country | United States |
| FEI number | 3014132885 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: