The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0823-2023·Announced 2023-06-07

Lidocaine HCl Jelly 2% recalled nationwide for manufacturing compliance deviations

Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.

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 manufacturing compliance deviations; no reported illnesses or injuries documented. Rated High because the inability to complete stability testing creates a risk-of-harm scenario without documented adverse events.

Plain-English summary

Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes distributed nationwide in the United States and Puerto Rico. This is a prescription-only product. The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility.

The firm went out of business and was unable to complete the stability studies required by federal regulations. These studies ensure that a drug maintains its quality, strength, and safety throughout its shelf life. Without completion of this testing, the long-term stability and safety profile of the product cannot be verified.

Affected consumers should not use this product and should consult their healthcare provider about alternative medications.

The recalled product

Product
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Topical / Jelly
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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