The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0821-2023·Announced 2023-06-07

Lidocaine-Prilocaine Cream Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Lidocaine 2.5% & Prilocaine 2.5% Cream due to CGMP deviations. The manufacturer went out of business and could not complete required stability studies to verify product integrity.

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: This is an FDA Class II recall due to CGMP deviations with no reported illnesses or injuries. The recall is driven by the firm's inability to complete stability studies, making it a precautionary, compliance-driven action rather than a response to documented harm.

Plain-English summary

Akorn, Inc. is recalling all lots of Lidocaine 2.5% & Prilocaine 2.5% Cream due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and was unable to continue the stability studies required to verify that the product maintains its safety and effectiveness throughout its shelf life.

The affected product is a prescription cream available in 30-gram tubes, manufactured by HI-TECH PHARMACAL CO., INC. (Amityville, NY). All lot numbers were distributed nationwide in the USA and Puerto Rico.

Patients and healthcare providers should not use the recalled product. Anyone currently taking this medication should consult their healthcare provider or pharmacist about alternative treatment options.

The recalled product

Product
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Topical 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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