FDA recall D-0525-2025

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

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.

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-06-30
Report date: 2025-07-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2025