Zydus Pharmaceuticals (USA) Inc: Drug Recall in 2026 - (Recall #: D-0400-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7

Product Classification:

Class II

Date Initiated: March 9, 2026

Date Posted: March 18, 2026

Recall Number: D-0400-2026

Event ID: 98560

Reason for Recall:

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Status: Ongoing

Product Quantity: 60,541 bottles

Code Information:

Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr

Distribution Pattern:

Nationwide in the USA

Voluntary or Mandated:

Voluntary: Firm initiated