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 testing for moisture content during routine stability testing. The affected medication is a prescription drug with NDC number 0904-7495-06, and the recall impacts all 50 U.S. states and Washington, D.C.
- 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.
- 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/2b0aaadf-d89b-4d00-add0-7705b8a28651