The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 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 86 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · unverified stability

See all →

Similar recalls