Zydus Pharmaceuticals (USA) Inc 2026-01-28 Health serious FDA
Health · FDA · Recall #FDA-D-0295-2026
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel… Recall
Issued January 28, 2026 · Zydus Pharmaceuticals (USA) Inc
In January 2026, Zydus Pharmaceuticals (USA) Inc recalled the Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
What you should do
- 1 Stop using Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zydus Pharmaceuticals (USA) Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zydus Pharmaceuticals (USA) Inc
- Category
- Health
- Recall date
- January 28, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-D-0295-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Zydus Pharmaceuticals (USA) Inc has 31 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.