# FDA recall D-0027-2022

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2021-10-08.

## Product

Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775  India NDC# 68180-316-06

## Reason for recall

Out of specification result observed in a dissolution test at the 9-month long term stability time point.

## Distribution

Distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0027-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-08
- **Report date:** 2021-10-27
- **Termination date:** 2023-03-13

- **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-0027-2022

## Citation

> AI Analytics. FDA recall D-0027-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0027-2022. Source: US FDA. Licensed CC0.

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