Zydus Icosapent Ethyl Capsules Recall: Oxidation Risk in 1g Bottles
Zydus Pharmaceuticals recalls 1g Icosapent Ethyl capsules (NDC 70710-1592-07) due to oxidation from capsule leakage. Affected lots expire 2/2027 or 4/2027. Stop using if you have these capsules.
Lower-risk recall
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
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What happened, in plain English
Zydus Pharmaceuticals is recalling 1-gram Icosapent Ethyl capsules that may have oxidized due to leakage. This could reduce the drug's effectiveness, but the recall does not mention serious injury risks. The affected capsules are prescription-only and sold in 120-count bottles. Read more at govinfonow.com/recall/31571-zydus-icosapent-ethyl-capsules-recall-oxidation-risk-in-1g-bottles.
Source Summary by GovInfoNow · govinfonow.com/recall/31571-zydus-icosapent-ethyl-capsules-recall-oxidation-risk-in-1g-bottles · Updated August 17, 2026 · FDA enforcement record: FDA #D-0295-2026
Cite this page
“Zydus Icosapent Ethyl Capsules Recall: Oxidation Risk in 1g Bottles.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31571-zydus-icosapent-ethyl-capsules-recall-oxidation-risk-in-1g-bottles. Based on FDA recall #D-0295-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0295-2026%22&limit=1).
Why it’s dangerous
The capsules may leak, causing oxidation that reduces the drug's potency. This means the medication might not work as intended, but the recall does not indicate a risk of injury or serious health effects.
Who’s affected
Prescription patients who received Icosapent Ethyl capsules with the specific lot numbers listed in the recall. Those with the capsules distributed by Zydus Pharmaceuticals (USA) Inc in the U.S. are most at risk.
How to tell if you have this one
Check for the NDC number 70710-1592-07 on the bottle. Look for lot numbers S2520304, S2520333 (expiring 2/28/2027) or S2540186 (expiring 4/30/2027). The capsules are prescription-only and sold in 120-count bottles.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Capsule Lot Number
Look for lot numbers S2520304, S2520333 (expiring 2/28/2027) or S2540186 (expiring 4/30/2027) on the bottle.
Stop Using if Affected
If you have the recalled lot numbers, stop using the capsules immediately as they may be less effective.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0295-2026 (December 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0295-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.