# FDA recall D-0377-2025

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2025-04-10.

## Product

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01

## Reason for recall

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-0377-2025
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2025-04-10
- **Report date:** 2025-04-30
- **Termination date:** 2026-01-05

- **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-0377-2025

## Citation

> AI Analytics. FDA recall D-0377-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0377-2025. Source: US FDA. Licensed CC0.

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