Medications & Supplements/Prescription Drugs

Lupin Oxycodone Hydrochloride Tablets Recalled for Impurity Test Failure

Agency Publication Date: January 5, 2022

Summary

Lupin Pharmaceuticals Inc. is recalling 23,965 bottles of Oxycodone Hydrochloride Tablets (5 mg, 100-count) because testing showed levels of an impurity that exceeded quality standards. This medication was manufactured by Novel Laboratories and distributed to pharmacies in New York and Ohio. No injuries or adverse health events have been reported in connection with this recall.

Risk

The tablets failed an impurity test at an 18-month stability checkpoint, meaning the product's chemical makeup no longer meets safety and quality specifications. While the risk level is considered low, consuming impurities beyond specified limits could lead to unintended health effects.

What You Should Do

The recalled product is Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, sold in 100-count bottles under the Lupin Pharmaceuticals brand with NDC 43386-432-01.
Identify affected bottles by checking for lot number S000268 with an expiration date of January 2022.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Oxycodone Hydrochloride Tablets, USP C-II, 5 mg (100 count)by Lupin Pharmaceuticals

Variants: 5 mg, 100 count bottles, Rx Only

Lot Numbers:

S000268 (Exp. date January 2022)

NDC:

43386-432-01

Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 for Lupin Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89324

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 23,965 100 count bottles

Distributed To: New York, Ohio

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, sold in 100-count bottles under the Lupin Pharmaceuticals brand with NDC 43386-432-01.

Identify affected bottles by checking for lot number S000268 with an expiration date of January 2022.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.