FDAClass IIIJanuary 19, 2022

Oxycodone Hydrochloride Oral Solution recall: Labeling Error

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville…

Why was Oxycodone Hydrochloride Oral Solution recalled?

Labeling: Missing Label

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?

Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023

Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville…
Recalling firm
Akorn, Inc.
Quantity
8184 bottles
Distribution
Nationwide USA
Recall date
January 19, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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