Akorn Lidocaine Hydrochloride Oral Topical Solution Recall

Why it was recalled

Failed viscosity specification - product was below specificcation

Product description

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

Lot numbers, UPCs & expiration codes

Lot #: 370978, Exp 9/30/2022

Where it was sold

Nationwide USA and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0846-2022
Classification: Class III
Status: Terminated
Recall initiated: Apr 15, 2022
FDA report date: May 11, 2022
Quantity: 66,744 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0846-2022, exactly as published.

Show all FDA fields

City: Lake Forest
State: IL
Status: Terminated
Country: United States
Event ID: 89993
Address: 1925 W Field Ct Ste 300
Code information: Lot #: 370978, Exp 9/30/2022
Postal code: 60045-4862
Report date: May 11, 2022
Product type: Drugs
Recall number: D-0846-2022
Classification: Class III
Recalling firm: Akorn, Inc.
Product quantity: 66,744 bottles
Termination date: Sep 28, 2023
Reason for recall: Failed viscosity specification - product was below specificcation
Voluntary / mandated: Voluntary: Firm initiated
Product description: Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04
Distribution pattern: Nationwide USA and Puerto Rico
Recall initiation date: Apr 15, 2022
Initial firm notification: Letter
Center classification date: May 5, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0846-2022, published May 11, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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