# FDA recall D-0542-2025

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2025-07-02.

## Product

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0542-2025
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-02
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Naples, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2025

## Citation

> AI Analytics. FDA recall D-0542-2025. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/D-0542-2025. Source: US FDA. Licensed CC0.

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