Medications & Supplements/Prescription Drugs

Akorn Morphine Sulfate and Oxycodone Hydrochloride Recalled for Missing Labels

Agency Publication Date: January 13, 2022

Summary

Akorn, Inc. is recalling approximately 19,020 bottles of Morphine Sulfate and Oxycodone Hydrochloride oral solutions because the bottles may be missing their identification labels. The recall includes 10,836 bottles of Morphine Sulfate (100 mg per 5 mL) and 8,184 bottles of Oxycodone Hydrochloride (5 mg per 5 mL) manufactured by Hi-Tech Pharmacal Co., Inc. These prescription opioid medications were distributed to pharmacies nationwide; no injuries or incidents have been reported to date.

Risk

The absence of a label on prescription opioid medications poses a high risk of medication errors, including taking the wrong drug or an incorrect dosage. This could lead to serious adverse health consequences or life-threatening overdose.

What You Should Do

This recall affects Morphine Sulfate Oral Solution (100 mg per 5 mL) sold in 30 mL bottles and Oxycodone Hydrochloride Oral Solution (5 mg per 5 mL) sold in 500 mL bottles.
Check your medication for the following identifiers: Morphine Sulfate (NDC 50383-965-30, lot 375153, Exp. 10/31/2022) or Oxycodone Hydrochloride (NDC 50383-961-34, lots 377186 Exp. 2/28/2023 or 377188 Exp. 3/31/2023).
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 Akorn, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

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: Morphine Sulfate Oral Solution (30 mL)by Hi-Tech Pharmacal Co., Inc.

Variants: 100 mg per 5 mL (20 mg/mL), Rx only

Lot Numbers:

375153 (Exp. 10/31/2022)

NDC:

50383-965-30

Quantity: 10,836 bottles

Product: Oxycodone Hydrochloride Oral Solution, USP (500 mL)by Hi-Tech Pharmacal Co., Inc.

Variants: 5 mg per 5 mL (1 mg/mL), Rx only

Lot Numbers:

377186 (Exp. 2/28/2023)

377188 (Exp. 3/31/2023)

NDC:

50383-961-34

Quantity: 8,184 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89142

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 2 products (10,836 bottles; 8184 bottles)

Distributed To: Nationwide

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

This recall affects Morphine Sulfate Oral Solution (100 mg per 5 mL) sold in 30 mL bottles and Oxycodone Hydrochloride Oral Solution (5 mg per 5 mL) sold in 500 mL bottles.

Check your medication for the following identifiers: Morphine Sulfate (NDC 50383-965-30, lot 375153, Exp. 10/31/2022) or Oxycodone Hydrochloride (NDC 50383-961-34, lots 377186 Exp. 2/28/2023 or 377188 Exp. 3/31/2023).

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 Akorn, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

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: Morphine Sulfate Oral Solution (30 mL)by Hi-Tech Pharmacal Co., Inc.

Variants: 100 mg per 5 mL (20 mg/mL), Rx only

Lot Numbers:

375153 (Exp. 10/31/2022)

NDC:

50383-965-30

Quantity: 10,836 bottles

Product: Oxycodone Hydrochloride Oral Solution, USP (500 mL)by Hi-Tech Pharmacal Co., Inc.

Variants: 5 mg per 5 mL (1 mg/mL), Rx only

Lot Numbers:

377186 (Exp. 2/28/2023)

377188 (Exp. 3/31/2023)

NDC:

50383-961-34

Quantity: 8,184 bottles