The Recall Desk
LowFDA (Drugs)·D-0367-2022·Announced 2022-01-19

Morphine Sulfate Oral Solution 20 mg/mL recalled for missing label

Akorn, Inc. is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) in 30 mL bottles nationwide due to missing labeling on approximately 10,836 bottles.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a labeling defect with no reported illnesses or injuries. Missing labels on pharmaceutical products are documentation/packaging issues that do not pose direct health hazards to patients receiving the drug under medical supervision in healthcare settings or through pharmacy dispensing.

Plain-English summary

Akorn, Inc. is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) in 30 mL bottles (NDC 50383-965-30) distributed nationwide. The recall affects Lot 375153 with expiration date 10/31/2022, totaling 10,836 bottles.

The reason for the recall is missing labeling on the affected bottles. This is a prescription-only medication manufactured by Akorn, Inc. and distributed by Hi-Tech Pharmacal Co., Inc., located in Amityville, NY.

Consumers and healthcare providers who have this product should stop using it and contact Akorn, Inc. or their pharmacy for instructions on proper return or disposal of the affected bottles.

The recalled product

Product
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
Manufacturer
Akorn, Inc.
Category
Drug — Opioid / Labeling
Hazard
  • missing-label

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 (1)

  • Lot: 375153 Exp. 10/31/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category