Omega-3-Acid recall
FDA recall D-0493-2026 · initiated Apr 9, 2026
The Harvard Drug Group LLC recalled Omega-3-Acid in Apr 2026 — an FDA Class II recall (D-0493-2026) because Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,238 5 x 10 unit dose cartons
Details
- 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
- Recalling company
- The Harvard Drug Group LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 9, 2026
- FDA report date
- Apr 29, 2026
Frequently asked
- Was Omega-3-Acid recalled?
- The Harvard Drug Group LLC recalled Omega-3-Acid in Apr 2026 — an FDA Class II recall (D-0493-2026) because Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Omega-3-Acid recalled?
- Per the FDA enforcement record, the reason for recall D-0493-2026 was: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
- Is a recalled Omega-3-Acid dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Omega-3-Acid are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0493-2026.