The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0807-2023·Announced 2023-06-07

Akorn Guaiatussin AC Sugar-Free Cough Suppressant Recalled Due to Manufacturing Deviations

Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free nationwide due to manufacturing deviations. The firm went out of business and could not continue stability studies.

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: This is an FDA Class II recall involving CGMP deviations and incomplete stability studies. No illnesses or injuries have been reported, and the hazard remains theoretical.

Plain-English summary

Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free, a cough suppressant containing guaifenesin (100 mg) and codeine phosphate (10 mg) per 5 mL dose. The product was distributed nationwide in the United States and Puerto Rico in 118 mL bottles, 473 mL bottles, and 100-unit dose cups.

The recall was initiated because Akorn, Inc. went out of business and could no longer continue stability studies. This represents a current good manufacturing practice (CGMP) deviation.

Patients currently using this product should consult their healthcare provider about alternatives. Any remaining product should be disposed of or returned to a pharmacy.

The recalled product

Product
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Cough Suppressant
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 →

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