# FDA recall D-0525-2025

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2025-06-30.

## 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

- **Recall number:** D-0525-2025
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-30
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall D-0525-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0525-2025. Source: US FDA. Licensed CC0.

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