# FDA recall D-0358-2022

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2021-12-29.

## Product

Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01

## Reason for recall

Out-of-specification impurity test result observed at 18-month long term stability time point.

## Distribution

Product Distributed in NY and OH.

## Key facts

- **Recall number:** D-0358-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-29
- **Report date:** 2022-01-12
- **Termination date:** 2022-08-23

- **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-0358-2022

## Citation

> AI Analytics. FDA recall D-0358-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0358-2022. Source: US FDA. Licensed CC0.

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