---
title: "Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... — FDA record D-0358-2022 | Is It on Recall"
description: "Out-of-specification impurity test result observed at 18-month long term stability time point."
url: https://isitonrecall.com/recall/fda-drug-d-0358-2022-oxycodone-hydrochloride-tablets-usp-c-ii-5-mg-100-count-bottles-rx-only-manufactured-for-lupin-pharm/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals,... — FDA record D-0358-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Out-of-specification impurity test result observed at 18-month long term stability time point.
- **Classification**: Class III
- **Recalling firm**: Lupin Pharmaceuticals Inc.
- **Quantity**: 23,965 100 count bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0358-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0358-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # S000268, Exp. date January 2022 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Product Distributed in NY and OH.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Jan 12, 2022
- **Recall initiation date**: Dec 29, 2021
- **Center classification date**: Jan 5, 2022
- **Termination date**: Aug 23, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0358-2022%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Lupin Pharmaceuticals Inc. records](https://isitonrecall.com/brand/lupin-pharmaceuticals-inc/)