Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The defect (Loss on Drying specification failure in capsule shells) is a manufacturing/quality control issue without documented adverse health consequences.
Plain-English summary
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters, Capsules, USP, 1 gram (50 capsules per carton, packaged and distributed by Major Pharmaceuticals) nationwide in the USA. The recall was initiated due to out-of-specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Approximately 2,238 cartons (5 x 10 unit dose blister packs per carton) are affected, specifically Lot N02406 (Exp 10/31/2026) and Lot N02845 (Exp 12/31/2026), NDC 0904-7495-06.
Patients currently taking this product should contact their healthcare provider or pharmacist for guidance. Consumers who have this medication should not stop taking it without consulting their healthcare provider.
The recalled product
- Product
- OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
- Brand
- OMEGA-3-ACID ETHYL ESTERS
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: Lot N02406
- Exp 10/31/2026
- Lot N02845
- Exp 12/31/2026
Distribution
Distributed nationwide across the United States.
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