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
Recall Summary The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count packages) distributed nationwide because the capsule shells failed quality specifications during testing—specifically, they contained more moisture than allowed. This is a Class II recall, meaning the product could cause health problems but is unlikely to cause serious harm. The affected product was distributed across all U.S. states and is available only by prescription.
- Recalling firm
- The Harvard Drug Group LLC
- Product
- 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
- Reason
- Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-09
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/db41fd26-bc3d-47e3-b3bc-2eaf65166100