The Recall Desk
ModerateFDA (Drugs)·D-0368-2022·Announced 2022-01-19

Oxycodone Hydrochloride Oral Solution recalled for missing label

Akorn, Inc. is recalling Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL distributed nationwide due to missing label.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving a labeling defect (missing label). Class III recalls are typically scored 1 or 2; the moderate score reflects the safety-relevant nature of a missing label on a prescription opioid, which could lead to dosing or administration errors if the label information is not available to the dispensing pharmacist or patient.

Plain-English summary

Akorn, Inc. is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottles manufactured by Hi-Tech Pharmacal Co., Inc. The recall affects 8,184 bottles distributed nationwide in the United States.

The recall was initiated due to missing label on the affected product. The affected lots are Lot 377186 (Exp. 2/28/2023) and Lot 377188 (Exp. 3/31/2023), identified by NDC 50383-961-34.

Consumers and healthcare providers who have received this product should not use it and should contact Akorn, Inc. or their pharmacy for replacement product or instructions on proper disposition.

The recalled product

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, NY 11701 --- NDC 50383-961-34
Manufacturer
Akorn, Inc.
Category
Drug — Prescription Opioid / Labeling
Hazard
Affected units
8,184

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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