FDAClass IIIJanuary 12, 2022

Oxycodone Hydrochloride Tablets recall: Impurity Out of Spec

Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202.…

Why was Oxycodone Hydrochloride Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # S000268, Exp. date January 2022

Product
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202.…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
23,965 100 count bottles
Distribution
Product Distributed in NY and OH.
Recall date
January 12, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls