CLASS II Drug recall · Reported 18 Jun 2025 · FDA Enforcement Report
Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)
Zydus Pharmaceuticals is recalling Icosapent Ethyl Capsules per, distributed in Illinois, Mississippi, Pennsylvania. The recall was initiated on 30 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0497-2025
- FDA event ID
- 96964
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Brand
- Icosapent Ethyl
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 30 May 2025
- FDA classified
- 30 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 30 May 2025 | Recall initiated by company | |
| 18 Jun 2025 | Published in enforcement report | +19 days |
| 30 Jun 2025 | Classified by FDA | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Where it was distributed
IL, PA, & MS
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Which lots are affected?
Lot #s: B237040, B237041, Exp 10/31/2025
Where was it sold?
IL, PA, & MS
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Icosapent Ethyl recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |