The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1878-2019·Announced 2019-10-02

Akorn Recalls Lidocaine Hydrochloride Jelly Due to Metal Particulate Finding

Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2% due to a finding of metal particulate matter in the filling room. No particulates were identified in the product itself.

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: The recall is classified as FDA Class II. The hazard is a cGMP deviation involving metal particulates found on the filling line, with no particulates identified in the product itself and no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2%, 30 mL tubes (NDC 17478-711-30). The recall involves 10,543 tubes from Lot 9B21A, with an expiration date of 1/2022. The product was distributed nationwide within the United States and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. The firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation. The source text explicitly states that no particulates were identified in the product, but rather were identified on the filling line.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The product is prescription-only (Rx Only) and sterile.

The recalled product

Product
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Manufacturer
Akorn, Inc.
Category
Drug — Topical Anesthetic
Hazard
Affected units
10,543

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 (2)

  • Lot #: 9B21A
  • Exp. 1/2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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