The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0824-2023·Announced 2023-06-07

Akorn Lidocaine Oral Solution Recalled Due to Manufacturing Compliance Deviations

Akorn Operating Company is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution 2% distributed nationally because the firm ceased operations and could not complete required 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory and administrative in nature—the firm's inability to complete stability studies—rather than an identified safety defect with reported harm. This qualifies as a precautionary recall.

Plain-English summary

Akorn Operating Company LLC is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes distributed nationwide in the USA and Puerto Rico. The prescription medication is being recalled due to Good Manufacturing Practice (GMP) compliance deviations.

The firm went out of business and was unable to continue stability studies required to ensure the product maintains its safety and effectiveness during its shelf life. Stability studies are a critical part of demonstrating that a pharmaceutical product remains safe and effective until its expiration date.

This recall affects all lots of this product. Patients currently using this medication should consult with their healthcare provider or pharmacist about alternative treatments. Healthcare facilities and pharmacies should remove this product from their shelves.

The recalled product

Product
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. 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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