Class IIReported 2025-07-23

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10

Reason for Recall

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Recall Number

D-0525-2025

Classification

Class II

Status

Ongoing