The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0808-2023·Announced 2023-06-07

Guaifenesin Oral Solution Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Guaifenesin Oral Solution nationwide due to CGMP deviations. The manufacturer ceased operations before completing required stability testing to verify the product's safety and efficacy.

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 issued due to CGMP deviations stemming from the manufacturer's closure and inability to complete required stability studies. No illnesses or injuries have been reported; the recall is based on the theoretical risk posed by unverified product stability.

Plain-English summary

Akorn, Inc. is recalling all lots of Guaifenesin Oral Solution, 300 mg/15 mL (sugar-free, alcohol-free, Rx only, for institutional use), distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required to verify that the product maintains its safety and efficacy throughout its shelf life.

Healthcare facilities and institutional users who have received this product should consult with their pharmacist or healthcare provider regarding appropriate actions. Patients taking this medication should speak with their healthcare provider about alternative treatments.

The recalled product

Product
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
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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