Recall of Omega-3-Acid Ethyl Esters Capsules
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The Harvard Drug Group LLC is voluntarily recalling 2,238 cartons of Omega-3-Acid Ethyl Esters Capsules due to failed capsule specifications from routine stability testing.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
What Happened
The recall was initiated because of failed capsule specifications, specifically out of specification results for Loss on Drying of Capsule Shells during routine stability testing.
Which Products Are Affected
The affected product is Omega-3-Acid Ethyl Esters Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, distributed by Major Pharmaceuticals, Indianapolis, IN 46288, with NDC 0904-7495-06. A total of 2,238 cartons are involved, affecting Lot N02406 (expiration 10/31/2026) and Lot N02845 (expiration 12/31/2026). The product was distributed nationwide in the USA.
What You Should Do
Consumers should contact the recalling firm, The Harvard Drug Group LLC, for instructions, as the initial notification was made via letter. Stop using the affected lots and follow the firm's guidance for returns or refunds.
Why This Matters
This recall involves a prescription drug with potential quality issues that could affect its efficacy, highlighting the importance of proper manufacturing standards in pharmaceuticals to ensure patient safety.
Source
FDA Recall Number D-0493-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,132 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.