Drug Enforcement D-0525-2025

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

Status

Ongoing

Classification

Class II

Report Date

July 23, 2025

Termination Date

—

Product Information

Product description
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
Product quantity
1476 bottles
Reason for recall
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0525-2025
Event ID
97161
Recall initiation date
June 30, 2025
Center classification date
July 14, 2025
Code info
Lot: C2403017, Exp 12/31/2026
More code info
—