# FDA recall D-0097-2018

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2017-11-21.

## Product

Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068

## Reason for recall

Failed Dissolution Specification

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0097-2018
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-21
- **Report date:** 2017-12-06
- **Termination date:** 2019-04-15

- **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-0097-2018

## Citation

> AI Analytics. FDA recall D-0097-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0097-2018. Source: US FDA. Licensed CC0.

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