The Recall Desk
HighFDA (Drugs)·D-0780-2023·Announced 2023-06-07

Acetaminophen & Codeine Oral Solution Recalled Due to Unverified Stability

Akorn, Inc. is recalling all lots of Acetaminophen & Codeine Oral Solution because stability studies cannot be completed. The firm ceased operations and cannot verify the medication's potency and safety.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is inability to verify medication stability through required studies, making this a risk-of-harm situation where actual adverse consequences have not yet been reported.

Plain-English summary

Akorn, Inc. is recalling all lots of Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL. This prescription medication is supplied in 473mL bottles and 40-unit-dose cups.

The manufacturer went out of business and cannot complete stability studies required by current Good Manufacturing Practice regulations.

The product was distributed nationwide in the United States and Puerto Rico. All lots are affected. Patients currently taking this medication should contact their healthcare provider or pharmacist about their medication supply.

The recalled product

Product
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Prescription Oral Solution
Hazard
  • unverified-stability

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)

  • All Lots

Distribution

Distributed nationwide across the United States.

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