The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0822-2023·Announced 2023-06-07

Lidocaine Ointment USP Recalled Due to Manufacturing Process Deviations

Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.

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 hospitalizations. The hazard (incomplete stability studies due to firm closure) is precautionary and compliance-related rather than indicative of known patient harm.

Plain-English summary

Akorn, Inc. is recalling all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes, Rx Only), manufactured for HI-TECH PHARMACAL CO., INC. The recall affects products distributed nationwide in the USA and Puerto Rico.

The reason for the recall is CGMP (Current Good Manufacturing Practice) deviations. The firm went out of business and could no longer continue the stability studies required by FDA regulations. Stability studies are critical to ensure that a pharmaceutical product maintains its strength, quality, and purity throughout its shelf life.

Patients currently using this product should consult with their healthcare provider about continuing use or obtaining an alternative. Dispensed and distributed units remain subject to return or destruction as directed by the FDA.

The recalled product

Product
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Topical Local Anesthetic
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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