The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0143-2023·Announced 2023-01-25

Lidocaine Hydrochloride Jelly Recalled for Manufacturing Quality Deviations

Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly due to manufacturing quality deviations. The product, distributed nationwide, is available in 5 mL and 30 mL prescription-only tubes.

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 voluntary, firm-initiated recall due to manufacturing quality deviations. This fits the rubric criterion of 'voluntary precautionary recalls' for a Moderate severity rating.

Plain-English summary

Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly USP, 2%. The affected product includes 5 mL tubes (NDC 17478-711-10) packaged 10 per box and 30 mL tubes (NDC 17478-711-30), distributed nationwide.

The recall is due to Current Good Manufacturing Practices (CGMP) deviations identified during manufacturing. Multiple lot codes are affected with expiration dates ranging from December 2022 through March 2025.

Consumers and healthcare providers should discontinue use of affected lots and verify their inventory against the recalled lot numbers and expiration dates provided by the FDA.

The recalled product

Product
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
Manufacturer
Akorn, Inc.
Category
Drug — Topical Anesthetic
Hazard
Affected units
2,369,258

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 (20)

  • Lot: (a) 0A02B
  • 0A02D
  • 0A02C
  • 0A02A
  • 0A02E
  • EXP 12/31/2022
  • 0B60C
  • 0B46B
  • 0B60D EXP 1/31/2023
  • 0B67B
  • 0B67D
  • 0B60B
  • 0B60A
  • 0B67A
  • 0B46D
  • 0B67C
  • 0B46A
  • EXP 1/31/2023
  • 0C78B
  • 0C78D

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

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