Zydus Pharmaceuticals (USA) Inc recalled Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, due to failed capsule specifications including red dots and melted capsules caused by oxidized active ingredient, the FDA said on March 9, 2026.
How to tell if you have it
- Brand: Zydus Pharmaceuticals
- Product: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle
- NDC: 70710-1592-7
- Lot codes: S2520249, S2520250, S2520267 (Exp. Date 2027/Jan); S2520303, S2520305, S2520332 (Exp. Date 2027/Feb); S2540208, S2540209 (Exp. Date 2027/Apr)
- Units affected: 60,541 bottles
- Distribution: Nationwide in the USA
The hazard
The recall cites failed Tablet/Capsule specifications where red dots inside the capsule and melted capsules resulted from oxidized Icosapent ethyl, the active ingredient. The FDA reported 1,163 adverse-event reports in its FAERS database naming this product, with 850 marked serious and 144 listing a death; these are unverified reports not findings about this recall.
Context
GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since March 14, 2012. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (August 5, 2026), Zydus Erythromycin Tablets Recall (April 29, 2026), and Zydus Icosapent Ethyl Capsules Recall (December 30, 2025). Other recent recalls of similar products include Harvard Drug Group Omega-3 Capsules Recall (April 9, 2026), Sun Pharmaceutical Lisdexamfetamine Capsules Recall (October 28, 2025), and Ajanta Pharma Fenofibrate Capsules Recall (May 28, 2026).