# FDA recall D-0052-2025

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2024-10-23.

## Product

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

## Reason for recall

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

## Distribution

Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.

## Key facts

- **Recall number:** D-0052-2025
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-10-23
- **Report date:** 2024-11-27
- **Termination date:** 2026-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0052-2025

## Citation

> AI Analytics. FDA recall D-0052-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0052-2025. Source: US FDA. Licensed CC0.

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